Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia
Conditions
Brief summary
This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed description
OBJECTIVES: I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed chronic lymphocytic leukemia. OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia \[CLL\] vs transformed CLL). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
Interventions
Given IV
Correlative studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of chronic lymphocytic leukemia (CLL) * Relapsed, refractory, or transformed disease * Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression * Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody * Transformed CLL (Richters transformation), must meet both of the following criteria: * Histologically confirmed lymphoma * Measurable disease * No CNS disease * Performance status - ECOG 0-2 * Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease) * SGOT and SGPT \< 3 times upper limit of normal * Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present * No history of 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 concurrent uncontrolled illness * See Disease Characteristics * No concurrent prophylactic hematopoietic colony-stimulating factors * See Disease Characteristics * More than 2 weeks since prior cytotoxic chemotherapy and recovered * More than 2 weeks since prior radiotherapy and recovered * No other concurrent investigational or antitumor agents * No other concurrent cytotoxic agents * No concurrent combination antiretroviral therapy for HIV-positive patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response (CR or PR) | 6 months | Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available). |
Countries
United States