Expired Study
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Fort Wayne, Indiana 46885


Purpose:

RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.


Study summary:

OBJECTIVES: - Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779. - Determine the toxicity and safety of this drug in these patients. - Correlate the degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in patients treated with this drug. - Correlate CCI-779 induced inactivation of mTOR with response in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease (aggressive lymphoma [group A] vs follicular lymphoma [group B] vs small lymphocytic lymphoma or chronic lymphocytic leukemia [group C]). 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. PROJECTED ACCRUAL: A total of 47-106 patients (13-32 for the aggressive lymphoma stratum and 17-37 each for the other 2 strata) will be accrued for this study within 21-24 months.


Criteria:

DISEASE CHARACTERISTICS: - 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 - 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 - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 50, 000/mm^3 (> 20,000/mm^3 for patients with thrombocytopenia due to bone marrow involvement) Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2.5 times ULN Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - 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 - Fasting cholesterol ≤ 350 mg/dL - Fasting triglycerides ≤ 400 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent prophylactic hematopoietic colony-stimulating factors - No concurrent pegfilgrastim Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - 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


NCT ID:

NCT00084474


Primary Contact:

Principal Investigator
Sonali M. Smith, MD
University of Chicago


Backup Contact:

N/A


Location Contact:

Fort Wayne, Indiana 46885
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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