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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060255 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.
Condition | Intervention | Phase |
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Breast Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: busulfan Drug: carboplatin Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: melphalan Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors |
Estimated Enrollment: | 450 |
Study Start Date: | July 1991 |
OBJECTIVES:
OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk includes acute leukemia in first relapse or second remission; lymphoma in responding first relapse or second remission; or breast cancer at risk for recurrence. High risk includes all others. Patients receive specific conditioning regimens according to diagnosis as outlined below.
Conditioning
Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4. Patients undergo TBI on days
3 to -1.
Patients receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
Stem Cell Infusion
PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen) will be accrued for this study within 10 years.
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic or solid tumor malignancy, including any of the following:
Acute myeloid leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia
Lymphoproliferative diseases*
Amyloidosis
NHL (intermediate- and high-grade)
First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse
Hodgkin's lymphoma
Solid tumors
Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:
Hormone receptor status:
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Prior cumulative doses of radiotherapy must not exceed the following:
Surgery
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Philip L. McCarthy, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000301587, RPCI-DS-9115 |
Study First Received: | May 6, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00060255 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer male breast cancer recurrent malignant testicular germ cell tumor Waldenstrom macroglobulinemia childhood acute lymphoblastic leukemia in remission adult acute lymphoblastic leukemia in remission recurrent adult acute myeloid leukemia adult acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia childhood acute myeloid leukemia in remission chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia refractory chronic lymphocytic leukemia recurrent adult diffuse large cell lymphoma |
recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent/refractory childhood Hodgkin lymphoma unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific |
Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Breast Cancer, Male Follicular Lymphoma Acute Myelocytic Leukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Etoposide Hodgkin Disease Breast Diseases Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Testicular Cancer Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Carmustine Breast Neoplasms Carboplatin Testicular Neoplasms Leukemia, Myeloid Thiotepa Multiple Myeloma Waldenstrom Macroglobulinemia B-cell Lymphomas Breast Neoplasms, Male Leukemia, Myeloid, Accelerated Phase |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Leukemia Neoplasms by Site Hemorrhagic Disorders Therapeutic Uses Neoplasms, Germ Cell and Embryonal Cardiovascular Diseases Alkylating Agents |
Lymphoma Breast Diseases Neoplasms by Histologic Type Immunoproliferative Disorders Skin Diseases Immune System Diseases Hematologic Diseases Carmustine Vascular Diseases Breast Neoplasms Carboplatin Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Lymphatic Diseases |