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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004231 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: aldesleukin Biological: filgrastim Biological: recombinant interferon alfa Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Drug: prednisone Drug: teniposide Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma |
Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy consisting of cyclophosphamide IV, doxorubicin IV, and teniposide IV over 2 hours on day 1, oral prednisone on days 1-5, vincristine IV and methotrexate IV over 2 hours on day 21, cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22, and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover. Treatment repeats every 42 days for 2 courses.
Patients achieving complete response or partial response receive an additional course of induction therapy. Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation.
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation (BMT). Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 3.5 days. At 24 hours following the last dose of busulfan, patients receive cyclophosphamide IV over 2 hours daily for 2 days. Patients receive allogeneic bone marrow infusion on day 0.
Patients under 50 years with no HLA matched donor or patients 50-65 years old undergo autologous bone marrow or peripheral blood stem cell (PBSC) transplantation. Patients undergo PBSC mobilization following completion of cyclophosphamide, doxorubicin, and teniposide portion of induction therapy of course 3. Patients receive cytokines subcutaneously (SQ) beginning 2 days following chemotherapy and continuing through PBSC collection. If insufficient stem cells are collected and there is negative bone marrow involvement, patients undergo bone marrow harvest. Patients receive a conditioning regimen consisting of busulfan and cyclophosphamide as for allogeneic BMT. Patients receive autologous bone marrow or PBSC infusion on day 0 and filgrastim (G-CSF) SQ beginning on day 0 and continuing until blood counts recover. Following blood count recovery, patients receive maintenance therapy consisting of interferon alfa SQ and interleukin-2 SQ daily over 5 consecutive days for 4 weeks. Treatment repeats every 8 weeks for 2 courses.
Patients 65 years or older achieving complete or partial response to induction chemotherapy receive maintenance therapy as for autologous BMT. Patients achieving partial response may receive an additional 4th course of induction therapy prior to maintenance therapy.
Patients are followed at 30 days post transplant, every 3 months for 1 year, and then at least every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study over 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma
Measurable or evaluable disease with at least one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611 |
Study Chair: | Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067473, NU-96H3, NCI-G99-1659 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004231 History of Changes |
Health Authority: | United States: Federal Government |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
Anti-Inflammatory Agents Prednisone Lymphoma, Mantle-Cell Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Mantle Cell Lymphoma Hormones Methotrexate Immunoproliferative Disorders Anti-HIV Agents Antineoplastic Agents, Hormonal Vincristine Glucocorticoids Doxorubicin Teniposide |
Folic Acid Aldesleukin Lymphoma, Non-Hodgkin Interferon Alfa-2a Antineoplastic Agents, Phytogenic Antimetabolites Interferon Type I, Recombinant Immunologic Factors Leucovorin Cyclophosphamide Anti-Bacterial Agents Anti-Retroviral Agents Vitamins Micronutrients Lymphoma |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Lymphoma, Mantle-Cell Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Therapeutic Uses Abortifacient Agents Methotrexate Angiogenesis Modulating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Anti-HIV Agents Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Teniposide Neoplasms Aldesleukin Interferon Alfa-2a Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites |