Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.

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

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically or cytologically confirmed relapsed or chemotherapy/immunotherapy-resistant mantle cell lymphoma

• No more than 3 lines of prior systemic treatment

• At least one measurable lesion ≥ 15 mm in its greatest transverse diameter by CT scan

Exclusion criteria:

• Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningosis)

• Newly diagnosed mantle cell lymphoma

• Patients suitable for intensive treatment (e.g., hyperfractionated cyclophosphamide, vincristine, doxorubicin hydrochloride and dexamethasone with high-dose methotrexate and cytarabine [HyperCVAD])

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status ≤ 2

• Creatinine clearance ≥ 30mL/min

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2 times ULN

• AST and ALT ≤ 2 times ULN

• Neutrophils ≥ 1,500/mm³ (≥ 1,000/mm³ with marrow infiltration)

• Thrombocytes ≥ 100,000/mm³ (≥ 75,000/mm³ in case of bone marrow infiltration)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 12 months after study participation

Exclusion criteria:

• Prior or concurrent hematological malignancies

• Patients with prior solid organ tumors that required no treatment over the last 5 years and are currently free of disease are eligible

• Cardiovascular disease including any of the following:

• NYHA class III or IV congestive heart failure

• Unstable angina pectoris

• Significant arrhythmia or arrhythmia requiring chronic treatment

• Myocardial infarction in the last 3 months

• Serious underlying medical condition which could impair the ability of the patient to participate in the trial including any of the following:

• Uncontrolled diabetes mellitus

• Gastric ulcers

• Active autoimmune disease

• Ongoing infection (e.g., HIV or hepatitis)

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

• Prior radiation where the indicator lesion(s) are in the irradiated field

• Prior organ transplantation

• Participation in another clinical trial within 30 days prior to study entry

• Concurrent anticancer drugs/treatments or experimental medications

• Other concurrent investigational therapy

• Other concurrent chemotherapy, immunotherapy, or radiotherapy (including palliative radiotherapy)