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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00516412 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: everolimus Procedure: molecular diagnostic method Procedure: polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma |
Estimated Enrollment: | 35 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue samples.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed relapsed or chemotherapy/immunotherapy-resistant mantle cell lymphoma
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Prior or concurrent hematological malignancies
Cardiovascular disease including any of the following:
Serious underlying medical condition which could impair the ability of the patient to participate in the trial including any of the following:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
France | |
Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting |
Tours, France, 37044 | |
Contact: Contact Person 32-24-747-3712 | |
CHU de Grenoble - Hopital de la Tronche | Recruiting |
Grenoble, France, 38043 | |
Contact: Contact Person 33-47-676-7575 | |
Hopital Haut Leveque | Recruiting |
Pessac, France, 33604 | |
Contact: Contact Person 33-55-765-6511 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Contact Person 33-14-211-4321 | |
Italy | |
European Institute of Oncology | Recruiting |
Milan, Italy, 20141 | |
Contact: Contact Person 39-02-5748-9538 | |
University of Bologna Medical School | Recruiting |
Bologna, Italy, 40138 | |
Contact: Contact Person 39-51-636-3680 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Switzerland, CH-1011 | |
Contact: Contact Person 41-21-314-0166 | |
City Hospital Triemli | Recruiting |
Zurich, Switzerland, CH-8063 | |
Contact: Contact Person 41-44-466-1268 | |
Hirslanden Klinik Aarau | Recruiting |
Aarau, Switzerland, CH-5001 | |
Contact: Contact Person 41-62-836-7833 | |
Hopitaux Universitaires de Geneve | Recruiting |
Thonex-Geneve, Switzerland, CH-1226 | |
Contact: Contact Person 41-22-372-9862 | |
Universitaetsspital-Basel | Recruiting |
Basel, Switzerland, CH-4031 | |
Contact: Contact Person 41-61-925-2710 | |
Kantonspital Aarau | Recruiting |
Aarau, Switzerland, CH-5001 | |
Contact: Contact Person 41-62-838-6053 | |
Kantonsspital - St. Gallen | Recruiting |
St. Gallen, Switzerland, CH-9007 | |
Contact: Contact Person 41-71-494-1066 | |
Kantonsspital Baden | Recruiting |
Baden, Switzerland, CH-5404 | |
Contact: Contact Person 41-56-486-2511 | |
Kantonsspital Graubuenden | Recruiting |
Chur, Switzerland, CH-7000 | |
Contact: Contact Person 41-81-256-7170 | |
Kantonsspital Olten | Recruiting |
Olten, Switzerland, CH-4600 | |
Contact: Contact Person 41-62-311-4241 | |
Kantonsspital Winterthur | Recruiting |
Winterthur, Switzerland, CH-8400 | |
Contact: Contact Person 41-52-266-3640 | |
Klinik Hirslanden | Recruiting |
Zurich, Switzerland, CH-8032 | |
Contact: Contact Person 41-44-387-3780 | |
UniversitaetsSpital Zuerich | Recruiting |
Zurich, Switzerland, CH-8091 | |
Contact: Contact Person 41-44-255-8902 | |
Inselspital Bern | Recruiting |
Bern, Switzerland, CH-3010 | |
Contact: Contact Person 41-31-632-8430 |
Principal Investigator: | Christoph Renner, MD | UniversitaetsSpital Zuerich |
Study ID Numbers: | CDR0000560438, SWS-SAKK-36/06, EU-20749, EUDRACT-2007-001108-19 |
Study First Received: | August 14, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00516412 |
Health Authority: | Unspecified |
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma recurrent mantle cell lymphoma |
stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Everolimus Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin |
Lymphoproliferative Disorders Mantle cell lymphoma Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |