Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
Trial ID or NCT#
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.
A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
- - > 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
- - 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
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