CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

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)