CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

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

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)

• Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy

• Unidimensionally measurable lymph node or lesion

• At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam

• One of the following measurement parameters may be used:

• Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin

• Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm^3

• No known CNS involvement (parenchymal mass or leptomeningeal involvement)

• Performance status - ECOG 0-2

• At least 3 months

• See Disease Characteristics

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 75,000/mm^3

• Hemoglobin ≥ 8 g/dL

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Direct bilirubin ≤ 1.5 times ULN

• AST ≤ 3 times ULN (5 times ULN if liver metastases are present)

• Creatinine ≤ 2 times ULN

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Cholesterol ≤ 350 mg/dL

• Triglycerides ≤ 400 mg/dL

• HIV negative

• No other active malignancy requiring treatment or that would preclude study participation

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• See Disease Characteristics

• Prior high-dose therapy with stem cell transplantation allowed

• At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers

• See Disease Characteristics

• See Biologic therapy

• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No other concurrent chemotherapy for MCL

• Concurrent corticosteroids for adrenal insufficiency allowed

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy

• No concurrent radiotherapy for MCL

• Any number of prior treatments allowed

• No other concurrent investigational or commercial agents for MCL

• No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)

• No concurrent immunosuppressive therapies