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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00090935 |
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with non-myeloid cancer.
PURPOSE: This clinical trial is studying how well epoetin alfa works in treating cancer-related anemia in patients with non-myeloid cancer who are not currently receiving chemotherapy or radiation therapy.
Condition | Intervention |
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Cancer-Related Problem/Condition Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: epoetin alfa |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | A Pilot Study To Evaluate The Response Rate Of Procrit (Epoetin Alfa) At 60,000 Units Every Two Weeks In Anemic Patients With Cancer Not Receiving Chemotherapy Or Radiation Therapy |
Study Start Date: | July 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized, pilot, multicenter study.
Patients receive epoetin alfa subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then at weeks 5, 9, 13, and 17.
Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cancer-related anemia (hemoglobin ≤ 11 g/dL for males OR ≤ 10 g/dL for females) AND meets one of the following criteria:
Receiving immunotherapy (i.e., interleukin-2 or interferon) or non-myelosuppressive therapy, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-6996 |
Study Chair: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000380849, UCLA-040304801, ORTHO-PR03-27-002 |
Study First Received: | September 7, 2004 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00090935 |
Health Authority: | United States: Federal Government |
anemia unspecified adult solid tumor, protocol specific Waldenstrom macroglobulinemia monoclonal gammopathy of undetermined significance isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma primary systemic amyloidosis stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage I adult Burkitt lymphoma stage I adult diffuse large cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse small cleaved cell lymphoma |
stage I adult Hodgkin lymphoma stage I adult immunoblastic large cell lymphoma stage I adult lymphoblastic lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage I mantle cell lymphoma stage I marginal zone lymphoma stage I small lymphocytic lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma |
Epoetin Alfa Sezary syndrome Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Lymphomatoid granulomatosis Mycoses Leukemia, Prolymphocytic Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Multiple Myeloma Waldenstrom Macroglobulinemia Plasmacytoma B-cell lymphomas Leukemia, T-Cell Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Hairy cell leukemia |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Hematinics |
Therapeutic Uses Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |