Overview

This trial is active, not recruiting.

Conditions leukemia, lymphoma, non-hodgkin
Treatment atorvastatin
Phase phase 2
Sponsor Dean Felsher
Collaborator The Leukemia and Lymphoma Society
Start date April 2005
End date December 2014
Trial size 23 participants
Trial identifier NCT00185731, 13683, 4328-07, 95140, LYMNHL0020

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Atorvastatin, 80mg tablet, will be taken orally by the patient daily, beginning on study day 1.
atorvastatin Lipitor
80 mg orally once daily

Primary Outcomes

Measure
Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.
time frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. Fine needle aspirate and blood samples are batched and analyzed within 1 year of obtaining each sample endpoint.

Secondary Outcomes

Measure
Determine validity of tumor bioactivity as a biologic endpoint by correlation with clinical response.
time frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment.
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.
time frame: Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - >18 years old - Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma subtypes: - Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL) - Extranodal marginal zone B-cell lymphoma - Nodal marginal zone B-cell lymphoma - Splenic marginal zone B-cell lymphoma - Treatment criteria - Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR - Prior treatment: watchful waiting currently appropriate o OR - Refractory disease - Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma) - CT chest (date) - CT abdomen (date) - CT pelvis (date) OR - Staging within 4 weeks prior to enrollment (CLL: CT not required) - Total White Cell Count (WBC) (Value) (date) - Absolute Lymphoma Cell Count (ALC) (Value) (date) - Measurable disease 1. (Site) 2. (Size) OR - 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) 1. Li absolute neutrophil count >1 ,000/uL 2. Li platelets >30,000/uL 3. Li total bilirubin within normal institutional limits 4. Li AST(SGOT) <2.5 X institutional upper limit of normal 5. Li ALT(SGPT) <2.5 X institutional upper limit of normal 6. 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 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 Information

Official title A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
Principal investigator Dean Felsher
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Stanford University.