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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00345865 |
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: carboplatin Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: rituximab Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy Procedure: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma |
Estimated Enrollment: | 150 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Chemo-mobilization: Patients requiring further disease reduction receive 1 of 2 chemo-mobilization regimens.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Ages Eligible for Study: | up to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes:
Precursor B-cell or precursor T-cell NHL
Mature B-cell lymphoma, including any of the following:
Mature T-cell lymphoma, including any of the following:
Hodgkin's lymphoma (HL) meeting the following criteria:
No resistant disease (initial disease or at relapse)
High-risk disease allowed, including any of the following:
Patients with lymphoma who are HIV positive are eligible as long as all of the following criteria are met:
HIV RNA viral load ≤ 100,000 copies/mL on each sample 4 weeks apart
PATIENT CHARACTERISTICS:
Hepatitis B carriers allowed
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Principal Investigator: | Marcie Tomblyn, MD, MS | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Marcie Tomblyn ) |
Study ID Numbers: | CDR0000483183, UMN-2005LS048, UMN-0508M72589, UMN-MT2004-24 |
Study First Received: | June 28, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00345865 |
Health Authority: | Unspecified |
HIV-associated Hodgkin lymphoma AIDS-related diffuse large cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related lymphoblastic lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related small noncleaved cell lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage I adult Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II adult Hodgkin lymphoma stage II childhood Hodgkin lymphoma |
stage III adult Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV childhood Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent cutaneous T-cell non-Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma |
Sezary syndrome Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Etoposide Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Rituximab Leukemia, B-cell, chronic Acquired Immunodeficiency Syndrome Carmustine Carboplatin HIV Infections Hodgkin lymphoma, childhood Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Leukemia, Lymphoid Hodgkin's disease Cutaneous T-cell lymphoma Lymphoma, Follicular Sezary Syndrome |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |