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Not Recruiting
Trial ID: NCT00185731
A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology
Ronald F. Dorfman, MBBch, FRCPath Professor of Hematopathology
Professor of Pathology
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
drug: Atorvastatin
Not Recruiting
Stanford University
School of Medicine
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Stanford,
CA
94305
ccto-office@stanford.edu
650-498-7061