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

Completed · Phase 2

Conditions studied: Leukemia, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT00185731

Run by

Dean Felsher

People needed

25

Starts

2005-04-01

Expected to finish

2012-11-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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