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| Sponsored by: |
Sylvester Cancer Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00450801 |
Purpose
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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with combination chemotherapy and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: leucovorin calcium Drug: methotrexate Drug: rituximab Drug: thalidomide Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (Maclo/Ivam) in Patients With Previously Untreated Mantle Cell Lymphoma |
| Estimated Enrollment: | 22 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive rituximab IV and doxorubicin hydrochloride IV over 3-5 minutes on day 1, vincristine IV on days 1 and 8, cyclophosphamide IV over 30 minutes on days 1-5, methotrexate IV over 24 hours on day 10, and leucovorin calcium IV every 6 hours beginning on day 11 and continuing until the level of methotrexate in the blood is within a safe range. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover. When absolute neutrophil count (ANC) reaches 1,500/mm^3, patients receive rituximab IV on day 1 (i.e., the day ANC reaches 1,500/mm^3), ifosfamide IV over 1 hour on days 1-5, cytarabine IV over 3 hours every 12 hours on days 1 and 2, and etoposide IV over 1 hour on days 1-5. Patients also receive G-CSF SC once daily beginning on day 7 and continuing until blood counts recover. Approximately 2-3 weeks later, patients receive another course of therapy as above.
Patients in complete remission after 2 courses of rituximab and combination chemotherapy receive oral thalidomide daily. Treatment with thalidomide continues for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |
| Study Chair: | Izidore S. Lossos, MD | Sylvester Cancer Center |
More Information
| Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center - Miami ( Izidore S. Lossos ) |
| Study ID Numbers: | CDR0000536468, SCCC-2003027, SCCC-20051242, SCCC-20030165 |
| Study First Received: | March 20, 2007 |
| Last Updated: | December 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00450801 |
| Health Authority: | Unspecified |
|
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 |
|
Immunoproliferative Disorders Thalidomide Rituximab Lymphoma, Mantle-Cell Vincristine Leucovorin Cyclophosphamide Etoposide phosphate Mantle cell lymphoma Doxorubicin Folic Acid Calcium, Dietary |
Lymphatic Diseases Ifosfamide Mechlorethamine Methotrexate Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Mesna Etoposide Lymphoma Cytarabine Isophosphamide mustard |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibiotics, Antineoplastic Anti-Bacterial Agents Therapeutic Uses Vitamins Abortifacient Agents Growth Inhibitors Angiogenesis Modulating Agents |
Micronutrients Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Growth Substances Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Angiogenesis Inhibitors Immunosuppressive Agents |
