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Sponsored by: |
University of Maryland Greenebaum Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003727 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with a peripheral stem cell transplant and immunotherapy 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: This phase II trial is studying giving chemotherapy together with a peripheral stem cell transplant followed by immunotherapy to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Biological: filgrastim Biological: recombinant interferon alfa Biological: sargramostim Biological: therapeutic autologous lymphocytes Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: gemcitabine hydrochloride Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Autotransplantation for Chronic Myelogenous Leukemia (CML) Followed by Immunotherapy With Ex-Vivo Expanded Autologous T Cells |
Estimated Enrollment: | 22 |
Study Start Date: | March 1999 |
OBJECTIVES:
OUTLINE: Patients undergo mononuclear cell leukapheresis to obtain T cells for ex-vivo expansion, preferably before they receive interferon alfa subcutaneously (SC) daily on a therapeutic trial.
At least 1 month after interferon is stopped, mobilization chemotherapy is administered. Patients receive cyclophosphamide IV over 12 hours on day 0, etoposide IV over 2 hours on day 1, sargramostim (GM-CSF) SC on days 3 and 4, and filgrastim (G-CSF) SC beginning on day 5. Peripheral blood stem cells (PBSC) are collected by leukapheresis when blood cell counts have recovered.
Approximately 2-3 weeks later, high-dose chemotherapy begins. Patients receive gemcitabine IV over 100 minutes on day -5, carmustine IV over 2 hours on day -2, followed 6 hours later by gemcitabine IV again, and melphalan IV over 20 minutes on day -1. CD34 selected PBSCs are infused on day 0, at least 18 hours after melphalan administration. Patients receive GM-CSF SC beginning on day 1 and continuing until blood cell counts recover.
Patients then receive ex vivo expanded autologous T cells on day 14 after autotransplantation. Interferon alfa is administered three times a week starting about 3 months after transplantation.
Patients who only receive expanded T cells, without high-dose chemotherapy and autotransplantation, but show no response after 3 months, may proceed to autotransplantation followed by a second ex vivo expanded T-cell infusion.
Patients are followed at 1, 2, 3, 6, 9, and 12 months, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 7-22 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia based on clinical features and molecular evidence for bcr/abl gene rearrangement
Should receive interferon alfa (IFN-A) with or without low-dose cytarabine for at least 3-6 months before autotransplantation and meet one of the following conditions:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 |
Study Chair: | Aaron P. Rapoport, MD | University of Maryland Greenebaum Cancer Center |
Study ID Numbers: | CDR0000066839, MSGCC-9851, MSGCC-1198006, NCI-V98-1513 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003727 History of Changes |
Health Authority: | United States: Federal Government |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia Philadelphia chromosome negative chronic myelogenous leukemia childhood chronic myelogenous leukemia |
Antimetabolites Philadelphia Chromosome Melphalan Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Leukemia, Myeloid, Chronic-Phase Cyclophosphamide Etoposide phosphate Leukemia Gemcitabine Etoposide Alkylating Agents Interferon-alpha Hematologic Diseases |
Interferons Carmustine Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Radiation-Sensitizing Agents Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Antineoplastic Agents, Alkylating Antirheumatic Agents Interferon Alfa-2a Bone Marrow Diseases |
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Gemcitabine Alkylating Agents |
Interferon-alpha Neoplasms by Histologic Type Hematologic Diseases Growth Substances Interferons Carmustine Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents |