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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00787969 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with cladribine and rituximab and to see how well it works in treating patients with newly diagnosed mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: cladribine Drug: temsirolimus Genetic: cytogenetic analysis Genetic: gene expression analysis Genetic: protein expression analysis Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial of Rituximab, Cladribine, and Temsirolimus (RCT) Therapy in Newly Diagnosed Mantle Cell Lymphoma (MCL) |
Estimated Enrollment: | 74 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of temsirolimus followed by a phase II study.
Patients receive rituximab IV on day 1 and cladribine IV over 2 hours on days 1-5. Patients then receive temsirolimus IV over 30 minutes on day 1; on days 1 and 15; on days 1, 8, and 15; or on days 1, 8, 15, and 22*. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 6-15 or pegfilgrastim SC on day 6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients enrolled in phase II receive temsirolimus at the maximum tolerated dose determined in phase I following a fixed schedule in a 28-day course.
Blood and tissue samples are collected at baseline and after course 2 for laboratory correlative studies. Samples are analyzed for serum free light chains, single nucleotide polymorphisms in host immune genes, vitamin D metabolites by liquid chromatography/tandem mass spectrometry, clinical metabolic markers (i.e., hyperglycemia or hyperlipidemia) as markers of mTOR inhibition, and PI3K pathway member expression.
After completion of study treatment, patients are followed periodically for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma
Measurable or assessable disease, defined as ≥ 1 of the following:
PATIENT CHARACTERISTICS:
No cardiac conditions, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior therapy for mantle cell non-Hodgkin lymphoma, including radiation therapy
No concurrent glucocorticoid steroids or other immunosuppressive therapies
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Principal Investigator: | David J. Inwards, MD | Mayo Clinic |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000619329, NCCTG-N078D |
Study First Received: | November 7, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00787969 History of Changes |
Health Authority: | Unspecified |
stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Cladribine Lymphatic Diseases Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Mantle-Cell |
Mantle Cell Lymphoma Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Immunosuppressive Agents Lymphoma |
Cladribine Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Rituximab Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |