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

Technical University of Munich

Status and phase: Terminated; Phase 2

Conditions: Lymphoma

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00727207

KRDI-TUM-CRAD001C2428

CDR0000597004

EUDRACT: 2007-005116-12

EU-20855

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

• Determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy.

Secondary

• Determine the toxicity and feasibility of treatment with this drug.
• Determine the efficacy of this drug in these patients.
• Compare the duration of remission after first- vs second-line chemotherapy.
• Determine the rate of objective remission.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 3 years.

Enrollment: 35 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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