Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
This study has been terminated.
(Lack of participations (8 of 25))
Sponsor:
Technische Universität München
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00727207
First received: July 31, 2008
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: everolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Technische Universität München:
Primary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity and feasibility [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
- Comparison of duration of remission after first- vs second-line chemotherapy [ Designated as safety issue: No ]
- Rate of objective remission [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | September 2014 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727207
Locations
| Germany | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
Sponsors and Collaborators
Technische Universität München
Investigators
| Principal Investigator: | Ulrich Keller, MD | Technische Universität München |
More Information
Additional Information:
No publications provided
| Responsible Party: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT00727207 History of Changes |
| Other Study ID Numbers: | CDR0000597004, KRDI-TUM-CRAD001C2428, EUDRACT: 2007-005116-12, EU-20855 |
| Study First Received: | July 31, 2008 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Technische Universität München:
|
recurrent mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma |
stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Everolimus Sirolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013