Status:
TERMINATED
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
Lead Sponsor:
Technical University of Munich
Conditions:
Lymphoma
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00727207
Start Date
May 1 2008
End Date
September 1 2014
Last Update
December 17 2012
Active Locations (1)
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1
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675