Phase 2
N=25
Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
Leukemia · Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT00185731 ↗Enrolled (actual)
25
Serious AEs
16.7%
Results posted
Dec 2017
Primary outcome: Primary: Tumor Apoptosis — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dean Felsher
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Apoptosis |
7 | — |
| SECONDARY Correlation of Tumor Apoptosis to Clinical Response |
-0.26 | — |
| SECONDARY Atorvastatin Toxicity |
4 | — |
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.
Eligibility 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 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 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
Data sourced from ClinicalTrials.gov (NCT00185731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.