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Phase II Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Lymphoma, Non-Hodgkin

Intervention: Atorvastatin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Dean Felsher

Official(s) and/or principal investigator(s):
Dean Felsher, Principal Investigator, Affiliation: Stanford University

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.

Clinical Details

Official title: A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: April 2005
Last updated: March 7, 2013

Page last updated: August 23, 2015

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