Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Niclosamide
Eligibility
Inclusion Criteria:
- Prior morphologically confirmed diagnosis of AML based on WHO Criteria
- Has previously failed all available and suitable therapies for AML Disease relapse or
the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented
by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable
to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg
PO BID) to control high WBC count is permitted.
- Age ≥ 2 and ≤ 25 years
- Body surface area (BSA) ≤ 2.10 m2, calculated per the Mostellar formula
- Must be able to tolerate po or ng medications.
- Performance status:
- Subject age
≤ 16 years old: Lansky score ≥ 50 > 16 years old: Karnofsky score ≥ 50%
- Life expectancy of greater than 4 weeks
- Platelets ≥ 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet
transfusion support is allowed)
- Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft
Gault) within 14 days prior to treatment initiation
- Total bilirubin ≤ 2.0 x Institutional upper limit of normal (ULN) within 14 days prior
to treatment initiation, unless the elevation is due primarily to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis or non
hepatic origin, and not to liver dysfunction
- SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT) ≤ 3.0 x ULN within 14 days prior to treatment
initiation
- Females of reproductive potential (WOCBP) must have a negative pregnancy test within
14 days prior to study treatment.
- WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of
birth control; abstinence; sterilized partner) for the duration of study participation
- Men only: Men must agree to use adequate contraception (eg, hormonal or barrier
methods of birth control; abstinence; sterilized partner) prior to the study treatment
(from date of consent), for the duration of study participation, and 30 days after
completion of niclosamide administration
- Ability to understand the purpose and risks of the study and the willingness to sign a
written informed consent document containing an authorization to use protected health
information (in accordance with national and local subject privacy regulations
Exclusion Criteria:
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
investigational therapy) within 2 weeks prior to starting study treatment.
Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to
control high WBC is permitted.
- Receiving any other investigational agents.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved
to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the
inclusion/exclusion criteria with the exception of alopecia
- Acute promyelocytic leukemia (French American British Class M3 AML)
- Known active central nervous system (CNS) leukemia; subjects can enroll on study if
CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the
treating physician
- Prior bone marrow transplant presenting with active uncontrolled graft versus host
disease (GvHD)
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel
disease or ulcerative colitis, or partial or complete bowel obstruction, at the time
of study entry
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- Lactating or pregnant female
- Known active hepatitis C
Ages Eligible for Study
2 Years - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters, RN, PNP
650-721-4074
I'm interested
Psoriasis Clinical Trials
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Niclosamide
Eligibility
Inclusion Criteria:
- Prior morphologically confirmed diagnosis of AML based on WHO Criteria
- Has previously failed all available and suitable therapies for AML Disease relapse or
the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented
by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable
to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg
PO BID) to control high WBC count is permitted.
- Age ≥ 2 and ≤ 25 years
- Body surface area (BSA) ≤ 2.10 m2, calculated per the Mostellar formula
- Must be able to tolerate po or ng medications.
- Performance status:
- Subject age
≤ 16 years old: Lansky score ≥ 50 > 16 years old: Karnofsky score ≥ 50%
- Life expectancy of greater than 4 weeks
- Platelets ≥ 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet
transfusion support is allowed)
- Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft
Gault) within 14 days prior to treatment initiation
- Total bilirubin ≤ 2.0 x Institutional upper limit of normal (ULN) within 14 days prior
to treatment initiation, unless the elevation is due primarily to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis or non
hepatic origin, and not to liver dysfunction
- SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT) ≤ 3.0 x ULN within 14 days prior to treatment
initiation
- Females of reproductive potential (WOCBP) must have a negative pregnancy test within
14 days prior to study treatment.
- WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of
birth control; abstinence; sterilized partner) for the duration of study participation
- Men only: Men must agree to use adequate contraception (eg, hormonal or barrier
methods of birth control; abstinence; sterilized partner) prior to the study treatment
(from date of consent), for the duration of study participation, and 30 days after
completion of niclosamide administration
- Ability to understand the purpose and risks of the study and the willingness to sign a
written informed consent document containing an authorization to use protected health
information (in accordance with national and local subject privacy regulations
Exclusion Criteria:
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
investigational therapy) within 2 weeks prior to starting study treatment.
Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to
control high WBC is permitted.
- Receiving any other investigational agents.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved
to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the
inclusion/exclusion criteria with the exception of alopecia
- Acute promyelocytic leukemia (French American British Class M3 AML)
- Known active central nervous system (CNS) leukemia; subjects can enroll on study if
CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the
treating physician
- Prior bone marrow transplant presenting with active uncontrolled graft versus host
disease (GvHD)
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel
disease or ulcerative colitis, or partial or complete bowel obstruction, at the time
of study entry
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- Lactating or pregnant female
- Known active hepatitis C
Ages Eligible for Study
2 Years - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters, RN, PNP
650-721-4074
I'm interested
Dermatology Clinical Trials
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Niclosamide
Eligibility
Inclusion Criteria:
- Prior morphologically confirmed diagnosis of AML based on WHO Criteria
- Has previously failed all available and suitable therapies for AML Disease relapse or
the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented
by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable
to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg
PO BID) to control high WBC count is permitted.
- Age ≥ 2 and ≤ 25 years
- Body surface area (BSA) ≤ 2.10 m2, calculated per the Mostellar formula
- Must be able to tolerate po or ng medications.
- Performance status:
- Subject age
≤ 16 years old: Lansky score ≥ 50 > 16 years old: Karnofsky score ≥ 50%
- Life expectancy of greater than 4 weeks
- Platelets ≥ 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet
transfusion support is allowed)
- Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft
Gault) within 14 days prior to treatment initiation
- Total bilirubin ≤ 2.0 x Institutional upper limit of normal (ULN) within 14 days prior
to treatment initiation, unless the elevation is due primarily to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis or non
hepatic origin, and not to liver dysfunction
- SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT) ≤ 3.0 x ULN within 14 days prior to treatment
initiation
- Females of reproductive potential (WOCBP) must have a negative pregnancy test within
14 days prior to study treatment.
- WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of
birth control; abstinence; sterilized partner) for the duration of study participation
- Men only: Men must agree to use adequate contraception (eg, hormonal or barrier
methods of birth control; abstinence; sterilized partner) prior to the study treatment
(from date of consent), for the duration of study participation, and 30 days after
completion of niclosamide administration
- Ability to understand the purpose and risks of the study and the willingness to sign a
written informed consent document containing an authorization to use protected health
information (in accordance with national and local subject privacy regulations
Exclusion Criteria:
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
investigational therapy) within 2 weeks prior to starting study treatment.
Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to
control high WBC is permitted.
- Receiving any other investigational agents.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved
to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the
inclusion/exclusion criteria with the exception of alopecia
- Acute promyelocytic leukemia (French American British Class M3 AML)
- Known active central nervous system (CNS) leukemia; subjects can enroll on study if
CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the
treating physician
- Prior bone marrow transplant presenting with active uncontrolled graft versus host
disease (GvHD)
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel
disease or ulcerative colitis, or partial or complete bowel obstruction, at the time
of study entry
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- Lactating or pregnant female
- Known active hepatitis C
Ages Eligible for Study
2 Years - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters, RN, PNP
650-721-4074
I'm interested
Pediatric Dermatology Clinical Trials
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Niclosamide
Eligibility
Inclusion Criteria:
- Prior morphologically confirmed diagnosis of AML based on WHO Criteria
- Has previously failed all available and suitable therapies for AML Disease relapse or
the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented
by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable
to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg
PO BID) to control high WBC count is permitted.
- Age ≥ 2 and ≤ 25 years
- Body surface area (BSA) ≤ 2.10 m2, calculated per the Mostellar formula
- Must be able to tolerate po or ng medications.
- Performance status:
- Subject age
≤ 16 years old: Lansky score ≥ 50 > 16 years old: Karnofsky score ≥ 50%
- Life expectancy of greater than 4 weeks
- Platelets ≥ 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet
transfusion support is allowed)
- Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft
Gault) within 14 days prior to treatment initiation
- Total bilirubin ≤ 2.0 x Institutional upper limit of normal (ULN) within 14 days prior
to treatment initiation, unless the elevation is due primarily to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis or non
hepatic origin, and not to liver dysfunction
- SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT) ≤ 3.0 x ULN within 14 days prior to treatment
initiation
- Females of reproductive potential (WOCBP) must have a negative pregnancy test within
14 days prior to study treatment.
- WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of
birth control; abstinence; sterilized partner) for the duration of study participation
- Men only: Men must agree to use adequate contraception (eg, hormonal or barrier
methods of birth control; abstinence; sterilized partner) prior to the study treatment
(from date of consent), for the duration of study participation, and 30 days after
completion of niclosamide administration
- Ability to understand the purpose and risks of the study and the willingness to sign a
written informed consent document containing an authorization to use protected health
information (in accordance with national and local subject privacy regulations
Exclusion Criteria:
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
investigational therapy) within 2 weeks prior to starting study treatment.
Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to
control high WBC is permitted.
- Receiving any other investigational agents.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved
to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the
inclusion/exclusion criteria with the exception of alopecia
- Acute promyelocytic leukemia (French American British Class M3 AML)
- Known active central nervous system (CNS) leukemia; subjects can enroll on study if
CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the
treating physician
- Prior bone marrow transplant presenting with active uncontrolled graft versus host
disease (GvHD)
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel
disease or ulcerative colitis, or partial or complete bowel obstruction, at the time
of study entry
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- Lactating or pregnant female
- Known active hepatitis C
Ages Eligible for Study
2 Years - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters, RN, PNP
650-721-4074
I'm interested
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Niclosamide
Eligibility
Inclusion Criteria:
- Prior morphologically confirmed diagnosis of AML based on WHO Criteria
- Has previously failed all available and suitable therapies for AML Disease relapse or
the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented
by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable
to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg
PO BID) to control high WBC count is permitted.
- Age ≥ 2 and ≤ 25 years
- Body surface area (BSA) ≤ 2.10 m2, calculated per the Mostellar formula
- Must be able to tolerate po or ng medications.
- Performance status:
- Subject age
≤ 16 years old: Lansky score ≥ 50 > 16 years old: Karnofsky score ≥ 50%
- Life expectancy of greater than 4 weeks
- Platelets ≥ 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet
transfusion support is allowed)
- Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft
Gault) within 14 days prior to treatment initiation
- Total bilirubin ≤ 2.0 x Institutional upper limit of normal (ULN) within 14 days prior
to treatment initiation, unless the elevation is due primarily to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis or non
hepatic origin, and not to liver dysfunction
- SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT) ≤ 3.0 x ULN within 14 days prior to treatment
initiation
- Females of reproductive potential (WOCBP) must have a negative pregnancy test within
14 days prior to study treatment.
- WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of
birth control; abstinence; sterilized partner) for the duration of study participation
- Men only: Men must agree to use adequate contraception (eg, hormonal or barrier
methods of birth control; abstinence; sterilized partner) prior to the study treatment
(from date of consent), for the duration of study participation, and 30 days after
completion of niclosamide administration
- Ability to understand the purpose and risks of the study and the willingness to sign a
written informed consent document containing an authorization to use protected health
information (in accordance with national and local subject privacy regulations
Exclusion Criteria:
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
investigational therapy) within 2 weeks prior to starting study treatment.
Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to
control high WBC is permitted.
- Receiving any other investigational agents.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved
to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the
inclusion/exclusion criteria with the exception of alopecia
- Acute promyelocytic leukemia (French American British Class M3 AML)
- Known active central nervous system (CNS) leukemia; subjects can enroll on study if
CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the
treating physician
- Prior bone marrow transplant presenting with active uncontrolled graft versus host
disease (GvHD)
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel
disease or ulcerative colitis, or partial or complete bowel obstruction, at the time
of study entry
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- Lactating or pregnant female
- Known active hepatitis C
Ages Eligible for Study
2 Years - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters, RN, PNP
650-721-4074
I'm interested
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Niclosamide
Eligibility
Inclusion Criteria:
- Prior morphologically confirmed diagnosis of AML based on WHO Criteria
- Has previously failed all available and suitable therapies for AML Disease relapse or
the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented
by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable
to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg
PO BID) to control high WBC count is permitted.
- Age ≥ 2 and ≤ 25 years
- Body surface area (BSA) ≤ 2.10 m2, calculated per the Mostellar formula
- Must be able to tolerate po or ng medications.
- Performance status:
- Subject age
≤ 16 years old: Lansky score ≥ 50 > 16 years old: Karnofsky score ≥ 50%
- Life expectancy of greater than 4 weeks
- Platelets ≥ 10,000/mm3 (for subjects with platelets < 10,000/mm3 at baseline, platelet
transfusion support is allowed)
- Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft
Gault) within 14 days prior to treatment initiation
- Total bilirubin ≤ 2.0 x Institutional upper limit of normal (ULN) within 14 days prior
to treatment initiation, unless the elevation is due primarily to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis or non
hepatic origin, and not to liver dysfunction
- SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT) ≤ 3.0 x ULN within 14 days prior to treatment
initiation
- Females of reproductive potential (WOCBP) must have a negative pregnancy test within
14 days prior to study treatment.
- WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of
birth control; abstinence; sterilized partner) for the duration of study participation
- Men only: Men must agree to use adequate contraception (eg, hormonal or barrier
methods of birth control; abstinence; sterilized partner) prior to the study treatment
(from date of consent), for the duration of study participation, and 30 days after
completion of niclosamide administration
- Ability to understand the purpose and risks of the study and the willingness to sign a
written informed consent document containing an authorization to use protected health
information (in accordance with national and local subject privacy regulations
Exclusion Criteria:
- Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
investigational therapy) within 2 weeks prior to starting study treatment.
Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to
control high WBC is permitted.
- Receiving any other investigational agents.
- Unresolved toxicities due to prior anticancer therapy, defined as not having resolved
to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the
inclusion/exclusion criteria with the exception of alopecia
- Acute promyelocytic leukemia (French American British Class M3 AML)
- Known active central nervous system (CNS) leukemia; subjects can enroll on study if
CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the
treating physician
- Prior bone marrow transplant presenting with active uncontrolled graft versus host
disease (GvHD)
- Known congenital bleeding disorders, including but not limited to hemophilia
- Known active uncontrolled systemic infection
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel
disease or ulcerative colitis, or partial or complete bowel obstruction, at the time
of study entry
- Inability to receive administration of niclosamide in the available formulation(s)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements
- Lactating or pregnant female
- Known active hepatitis C
Ages Eligible for Study
2 Years - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nancy Sweeters, RN, PNP
650-721-4074
I'm interested