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
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Mogamulizumab
- radiation: LD TSEBT
Eligibility
Inclusion Criteria:
- Stages 1B IV MF or SS
- 1 prior standard of care therapy
- Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as
progressive disease (PD) did not occur while on therapy, and did not discontinue due
to toxicities
- ≥ 18 years of age
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1
by the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 5.0 (NCI-CTCAE, v 5.0).
- MF and a known history of non-complicated staphylococcus colonization/infection is
eligible provided that stable doses of prophylactic antibiotics continue.
- The following minimum wash-out from previous treatments are required, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti-cancer/CTCL therapies
- ≥ 2 weeks for phototherapy, local radiation therapy
- ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod)
- ≥ 12 weeks for total skin electron beam therapy
- ≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
- Rapidly progressive malignant disease may be enrolled prior to above periods
after discussion with the Protocol Director.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN).
Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or
≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
graft vs host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months
after the last dose.
- Male participants and their female partners of child bearing potential must be willing
to use an appropriate method of contraception during the study and for 3 months after
the last dose.
Exclusion Criteria:
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral
prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at
least 4 weeks prior to study treatment)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
significant
- Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic
virus (HTLV-1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604
I'm interested
Psoriasis Clinical Trials
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Mogamulizumab
- radiation: LD TSEBT
Eligibility
Inclusion Criteria:
- Stages 1B IV MF or SS
- 1 prior standard of care therapy
- Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as
progressive disease (PD) did not occur while on therapy, and did not discontinue due
to toxicities
- ≥ 18 years of age
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1
by the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 5.0 (NCI-CTCAE, v 5.0).
- MF and a known history of non-complicated staphylococcus colonization/infection is
eligible provided that stable doses of prophylactic antibiotics continue.
- The following minimum wash-out from previous treatments are required, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti-cancer/CTCL therapies
- ≥ 2 weeks for phototherapy, local radiation therapy
- ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod)
- ≥ 12 weeks for total skin electron beam therapy
- ≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
- Rapidly progressive malignant disease may be enrolled prior to above periods
after discussion with the Protocol Director.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN).
Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or
≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
graft vs host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months
after the last dose.
- Male participants and their female partners of child bearing potential must be willing
to use an appropriate method of contraception during the study and for 3 months after
the last dose.
Exclusion Criteria:
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral
prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at
least 4 weeks prior to study treatment)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
significant
- Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic
virus (HTLV-1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604
I'm interested
Dermatology Clinical Trials
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Mogamulizumab
- radiation: LD TSEBT
Eligibility
Inclusion Criteria:
- Stages 1B IV MF or SS
- 1 prior standard of care therapy
- Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as
progressive disease (PD) did not occur while on therapy, and did not discontinue due
to toxicities
- ≥ 18 years of age
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1
by the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 5.0 (NCI-CTCAE, v 5.0).
- MF and a known history of non-complicated staphylococcus colonization/infection is
eligible provided that stable doses of prophylactic antibiotics continue.
- The following minimum wash-out from previous treatments are required, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti-cancer/CTCL therapies
- ≥ 2 weeks for phototherapy, local radiation therapy
- ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod)
- ≥ 12 weeks for total skin electron beam therapy
- ≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
- Rapidly progressive malignant disease may be enrolled prior to above periods
after discussion with the Protocol Director.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN).
Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or
≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
graft vs host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months
after the last dose.
- Male participants and their female partners of child bearing potential must be willing
to use an appropriate method of contraception during the study and for 3 months after
the last dose.
Exclusion Criteria:
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral
prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at
least 4 weeks prior to study treatment)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
significant
- Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic
virus (HTLV-1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604
I'm interested
Pediatric Dermatology Clinical Trials
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Mogamulizumab
- radiation: LD TSEBT
Eligibility
Inclusion Criteria:
- Stages 1B IV MF or SS
- 1 prior standard of care therapy
- Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as
progressive disease (PD) did not occur while on therapy, and did not discontinue due
to toxicities
- ≥ 18 years of age
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1
by the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 5.0 (NCI-CTCAE, v 5.0).
- MF and a known history of non-complicated staphylococcus colonization/infection is
eligible provided that stable doses of prophylactic antibiotics continue.
- The following minimum wash-out from previous treatments are required, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti-cancer/CTCL therapies
- ≥ 2 weeks for phototherapy, local radiation therapy
- ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod)
- ≥ 12 weeks for total skin electron beam therapy
- ≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
- Rapidly progressive malignant disease may be enrolled prior to above periods
after discussion with the Protocol Director.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN).
Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or
≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
graft vs host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months
after the last dose.
- Male participants and their female partners of child bearing potential must be willing
to use an appropriate method of contraception during the study and for 3 months after
the last dose.
Exclusion Criteria:
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral
prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at
least 4 weeks prior to study treatment)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
significant
- Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic
virus (HTLV-1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604
I'm interested
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Mogamulizumab
- radiation: LD TSEBT
Eligibility
Inclusion Criteria:
- Stages 1B IV MF or SS
- 1 prior standard of care therapy
- Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as
progressive disease (PD) did not occur while on therapy, and did not discontinue due
to toxicities
- ≥ 18 years of age
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1
by the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 5.0 (NCI-CTCAE, v 5.0).
- MF and a known history of non-complicated staphylococcus colonization/infection is
eligible provided that stable doses of prophylactic antibiotics continue.
- The following minimum wash-out from previous treatments are required, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti-cancer/CTCL therapies
- ≥ 2 weeks for phototherapy, local radiation therapy
- ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod)
- ≥ 12 weeks for total skin electron beam therapy
- ≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
- Rapidly progressive malignant disease may be enrolled prior to above periods
after discussion with the Protocol Director.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN).
Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or
≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
graft vs host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months
after the last dose.
- Male participants and their female partners of child bearing potential must be willing
to use an appropriate method of contraception during the study and for 3 months after
the last dose.
Exclusion Criteria:
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral
prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at
least 4 weeks prior to study treatment)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
significant
- Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic
virus (HTLV-1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604
I'm interested
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Mogamulizumab
- radiation: LD TSEBT
Eligibility
Inclusion Criteria:
- Stages 1B IV MF or SS
- 1 prior standard of care therapy
- Prior LD-TSEBT (> 3 months prior) and prior mogamulizumab is allowed, as long as
progressive disease (PD) did not occur while on therapy, and did not discontinue due
to toxicities
- ≥ 18 years of age
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1
by the National Cancer Institute Common Terminology Criteria for Adverse Events,
version 5.0 (NCI-CTCAE, v 5.0).
- MF and a known history of non-complicated staphylococcus colonization/infection is
eligible provided that stable doses of prophylactic antibiotics continue.
- The following minimum wash-out from previous treatments are required, if applicable.
- ≥ 4 weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or
other systemic anti-cancer/CTCL therapies
- ≥ 2 weeks for phototherapy, local radiation therapy
- ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen
mustard, or imiquimod)
- ≥ 12 weeks for total skin electron beam therapy
- ≥ 4 weeks for monoclonal antibodies; except > 12 weeks for alemtuzumab
- Rapidly progressive malignant disease may be enrolled prior to above periods
after discussion with the Protocol Director.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); or if known bone
marrow involvement, then ANC ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3); or if known bone marrow
involvement, then platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN).
Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or
≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of
graft vs host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months
after the last dose.
- Male participants and their female partners of child bearing potential must be willing
to use an appropriate method of contraception during the study and for 3 months after
the last dose.
Exclusion Criteria:
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral
prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at
least 4 weeks prior to study treatment)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically
significant
- Known human immunodeficiency virus (HIV) positivity; known human T-cell lymphotropic
virus (HTLV-1) infection; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who
started taking medication at least 30 days prior to the Screening Visit, and have no
active signs of active infection, and whose last active infection was more than 6
months ago, may enter the study, and should continue to take the prescribed medication
for the duration of the study.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604
I'm interested