Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

• Status: Terminated
• Trial end date: 2014-09-01
• 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 older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.

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

Details

• Lead Sponsor: Technische Universität München
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of mantle cell lymphoma

• Stable disease after first- or second-line chemotherapy

• No uncontrolled cerebral or leptomeningeal disease

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy ≥ 3 months

• Age ≥ 60 years or patients ≥ 40 and < 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin > 9 g/dL

• Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

• SGPT and SGOT ≤ 3 times ULN

• Bilirubin ≤ 1.5 times ULN

• No other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer

• No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness)

• No known HIV infection

• No gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis)

• No coagulation or bleeding diatheses

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Patients must have complied with their previous drug prescription

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• See Patient Characteristics

• Recovered from all prior therapy

• At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy

• More than 4 weeks since prior experimental medication

• No chronic therapy with systemic steroids or other immunosuppressants except rituximab

• No prior organ transplantation

• No therapy with vitamin K antagonist, except low-dose coumarin

• No prior mTOR inhibitors