CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
B-cell Chronic Lymphocytic Leukemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Malignant Neoplasm
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the following subtypes: Aggressive B-cell lymphoma (Group A) Diffuse large B-cell lymphoma Transformed lymphoma Follicular lymphoma (Group B) Small lymphocytic lymphoma Chronic lymphocytic leukemia (CLL) (Group C) Other B-cell small lymphocytic disorders No mantle cell lymphoma No potentially curative treatment options because of lack of response, relapse, or ineligibility Relapsed or refractory disease Patients with refractory disease (i.e., less than a partial response to the last treatment) must have received no more than 3 prior regimens (group A) Patients with sensitive disease (i.e., at least a partial response to the last treatment) must have received no more than 4 prior regimens (group A) Patients who have failed prior autologous transplantation are eligible (group A) No more than 5 prior regimens (groups B and C) The salvage regimen, conditioning regimen, and any maintenance therapy are considered 1 regimen Prior rituximab or alemtuzumab is not considered prior therapy No limitation to the amount of prior radiotherapy No CNS involvement Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy more than 3 months No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Completed therapy and considered < 30% risk of relapse No other concurrent uncontrolled illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent prophylactic hematopoietic colony-stimulating factors No concurrent pegfilgrastim More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered More than 4 weeks since prior radiotherapy and recovered No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum (St. John's wort) No other concurrent known inducers of CYP3A4 No other concurrent investigational agents No other concurrent anticancer therapy Measurable disease* At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan [Note: *Only bone marrow or peripheral blood involvement required for CLL and Waldenstrom's macroglobulinemia ] Absolute neutrophil count >= 1,000/mm3 Bilirubin =< 1.5 times upper limit of normal (ULN) AST and ALT =< 2.5 times ULN Creatinine =< 1.5 times ULN Fasting cholesterol =< 350 mg/dL Fasting triglycerides =< 400 mg/dL Platelet count >= 50, 000/mm3 (> 20,000/mm3 for patients with thrombocytopenia due to bone marrow involvement)
Sites / Locations
- University of Chicago
- Decatur Memorial Hospital
- Evanston Hospital CCOP
- Ingalls Memorial Hospital
- Adventist La Grange Memorial Hospital
- Loyola University Medical Center
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Northern Indiana Cancer Research Consortium
- University of Iowa
- Oncology Care Associates PLLC
- M D Anderson Cancer Center
- Froedtert and the Medical College of Wisconsin
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks.