NCT00290472

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

Official Title:

A Phase II Study of CCI-779 in B-cell Lymphoma and CLL

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.

Eligibility

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)

Disease(s) and\or Condition(s)

B-cell Chronic Lymphocytic Leukemia

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Malignant Neoplasm

Nodal Marginal Zone B-cell Lymphoma

Recurrent Adult Burkitt Lymphoma

Recurrent Adult Diffuse Large Cell Lymphoma

Recurrent Adult Diffuse Mixed Cell Lymphoma

Recurrent Adult Diffuse Small Cleaved Cell Lymphoma

Recurrent Adult Immunoblastic Large Cell Lymphoma

Recurrent Adult Lymphoblastic Lymphoma

Recurrent Grade 1 Follicular Lymphoma

Recurrent Grade 2 Follicular Lymphoma

Recurrent Grade 3 Follicular Lymphoma

Recurrent Marginal Zone Lymphoma

Recurrent Small Lymphocytic Lymphoma

Refractory Chronic Lymphocytic Leukemia

Splenic Marginal Zone Lymphoma

Waldenström Macroglobulinemia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: temsirolimus
    • Description:
    • Arm Group Labels: Arm I
Sponsor
  • National Cancer Institute (NCI)