Dean W. Felsher
Phase II study of Atorvastatin safety and antitumor effects in non-Hodgkin's Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to: 1. Determine changes in levels of tumor bioactivity upon treatment with atorvastatin. Secondary objective: 2. Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response. 3. Determine whether administration of atorvastatin is tolerable and safe in low grade NHL patients. We do not anticipate any significant toxicity since this dose of atorvastatin has been FDA approved for patients with hypercholesterolemia.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Atorvastatin
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- >18 years old
- Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin?s Lymphoma subtypes:
o Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
o Extranodal marginal zone B-cell lymphoma
o Nodal marginal zone B-cell lymphoma
o Splenic marginal zone B-cell lymphoma
- Treatment criteria
o Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR
o Prior treatment: watchful waiting currently appropriate o OR
o Refractory disease
- Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)
o CT chest (date)
o CT abdomen (date)
o CT pelvis (date)
OR
- Staging within 4 weeks prior to enrollment (CLL: CT not required)
o Total White Cell Count (WBC) (Value) (date)
o Absolute Lymphoma Cell Count (ALC) (Value) (date)
o Measurable disease
a. (Site)
b. (Size)
OR
o CLL (only): Elevated Absolute Lymphoma Cell Count
- Disease amenable to biopsy (must check at least one): Li circulating tumor cells
- Li positive bone marrow
- Li palpable involved site (such as lymph node) measuring >1.5 cm
ECOG performance status <2 (Karnofsky >60)
o Status score:
- Life expectancy of greater than 3 months
- Patients must have adequate organ and marrow function (EACH must
checked ?yes?) (Date)
a. Li absolute neutrophil count >1 ,000/uL
b. Li platelets >30,000/uL
c. Li total bilirubin within normal institutional limits
d. Li AST(SGOT) <2.5 X institutional upper limit of normal
e. Li ALT(SGPT) <2.5 X institutional upper limit of normal
f. Li creatinine within normal institutional limits
OR
creatinine clearance >60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have negative BetaHCG at enrollment
Key Exclusion Criteria:
- Patient has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patient has not recovered from adverse events due to agents administered more than four weeks earlier
- Patient with stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month
- Patient has not recovered from adverse events due to surgery performed 4 weeks earlier
- Patient is receiving any other investigational agent. Known brain metastases
- Patient has taken any statin within the past 6 months prior to enrollment in the trial
- Patient currently abuses alcohol
- Patient currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis
- Patient as uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient is pregnant. Note: Patients are not excluded if they are breastfeeding at the time of enrollment, but breastfeeding should be discontinued if the mother is treated with atorvastatin.
- HIV-positive patients receiving combination anti-retroviral therapy
Additional Study Details
Official Title:
A Phase II Study of Atorvastatin in Patients with Low Grade or Refractory non-Hodgkin's LymphomaAnticipated start date:
4/12/2005Lead Sponsor:
Stanford UniversityCollaborator(s):
- Leukemia & Lymphoma Society
- Damon Runyon Cancer Research Foundation
- Burroughs Wellcome Foundation
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.
Secondary Outcomes:
- Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response.
- Determine whether administration of atorvastatin is tolerable and safe in low grade NHL patients. We do not anticipate any significant toxicity since this dose of atorvastatin has been FDA approved for patients with hypercholesterolemia.
Total Number to be Enrolled:
17Total Number to be Enrolled at Stanford:
17More Information
Secondary ID(s):
- 4328-07
- 95140
- LYMNHL0020
- NCT00185731
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/9/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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