Clinical trial · Interventional
Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
NCT00185731CI-TRIAL-00030626completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 80 mg Atorvastatin
- description
- Atorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1.
- interventionNames
- Drug: Atorvastatin
Primary outcomes (1)
- measure
- Tumor Apoptosis
- timeFrame
- 1 year
- description
- Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
Secondary outcomes (2)
- measure
- Correlation of Tumor Apoptosis to Clinical Response
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.