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| Sponsored by: |
University of Maryland Greenebaum Cancer Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005946 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: etoposide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation |
| Study Start Date: | October 2000 |
OBJECTIVES: I. Determine the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease in patients with hematologic malignancies relapsed after allogeneic stem cell transplantation.
OUTLINE: This is a dose de-escalation study. Patients receive etoposide IV continuously on days 1-3; cyclophosphamide IV on day 8; donor lymphocyte infusion IV on day 10; and filgrastim (G-CSF) subcutaneously or IV beginning on day 10 and continuing until blood counts recover. Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease (GVHD) is determined. The target dose level is defined as the level at which 2 of 6 patients develop GVHD, and the next lower dose level has no more than 1 patient experiencing GVHD. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued over 2 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory hematologic malignancy Acute leukemia Myelodysplasia Non-Hodgkin's lymphoma Hodgkin's disease Multiple myeloma Chronic lymphocytic leukemia Chronic myeloid leukemia Accelerated phase or blast crisis Chronic phase with failed prior donor lymphocyte infusion No active acute or extensive chronic graft versus host disease Prior allogeneic stem cell transplant (SCT) required At least 60 days since prior SCT Nonmyeloablative SCT allowed
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 4 weeks Hematopoietic: Not specified Hepatic:
Not specified Renal: Not specified Other: No severe psychiatric illness that may preclude informed consent Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 7 days since prior immunomodulatory medications (e.g., interferon or interleukin-2) Chemotherapy: Not specified Endocrine therapy: At least 7 days since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 7 days since prior immunosuppressives (e.g., cyclosporine, tacrolimus, or mycophenolate mofetil) No concurrent immunosuppressive medications for graft versus host disease
Contacts and Locations| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Study Chair: | Bijoyesh Mookerjee, MD | Jefferson Medical College of Thomas Jefferson University |
More Information
| Study ID Numbers: | CDR0000067863, MSGCC-9951, NCI-V00-1588 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005946 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia recurrent/refractory childhood Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
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Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Preleukemia Acute Myelocytic Leukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Etoposide Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Hematologic Diseases Blood Coagulation Disorders Leukemia, Myeloid Multiple Myeloma B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Immunologic Factors Hematologic Neoplasms Precancerous Conditions Blood Protein Disorders Hodgkin Lymphoma, Childhood |
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Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Syndrome |
Cardiovascular Diseases Alkylating Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Lymphatic Diseases Neoplasms |
