Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dean Felsher
• Collaborators: Burroughs Wellcome; Damon Runyon Cancer Research Foundation; The Leukemia and Lymphoma Society
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• > 18 years old

• Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma (NHL) 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 blood cell count (WBC) (Value) (date)

• Absolute lymphoma cell count (ALC) (Value) (date)

• Measurable disease (Site) (Size) OR

• CLL (only): elevated absolute lymphoma cell count

• Disease amenable to biopsy (must check at least one):

• Circulating tumor cells

• Positive bone marrow

• Palpable involved site (such as lymph node) measuring > 1.5 cm

• Eastern Cooperative Oncology Group performance status <2 (Karnofsky >60)

• Life expectancy of greater than 3 months

• Patients must have adequate organ and marrow function

• Absolute neutrophil count > 1,000/uL

• Platelets > 30,000/uL

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio < 2.5 x institutional upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m² 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:

• Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study

• Not recovered from adverse events due to agents administered more than four weeks earlier

• Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month

• Not recovered from adverse events due to surgery performed 4 weeks earlier

• Receiving any other investigational agent. Known brain metastases

• Taken any statin within the past 6 months prior to enrollment in the trial

• Currently abuses alcohol

• Currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis

• Has 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.

• Pregnant: 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