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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004061 |
Purpose
RATIONALE: Biological therapy using growth factors may be effective in reducing side effects in patients who have hematologic cancer and are receiving radiation therapy, chemotherapy, and peripheral stem cell transplantation.
PURPOSE: Randomized phase II trial to study the effectiveness of biological therapy to reduce side effects in patients who are undergoing radiation therapy, chemotherapy, and peripheral stem cell transplantation in treating lymphoma or leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Oral Complications Quality of Life |
Biological: filgrastim Biological: palifermin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Procedure: peripheral blood stem cell transplantation Procedure: quality-of-life assessment Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | A Randomized Double-Blind, Placebo-Controlled Trial of Recombinant Human Keratinocyte Growth Factor (rHuKGF) in Patients With Hematologic Malignancies Undergoing Total Body Irradiation (TBI) and High-Dose Chemotherapy With Autologous Peripheral Blood |
| Estimated Enrollment: | 111 |
| Study Start Date: | May 1999 |
OBJECTIVES: I. Determine the efficacy of recombinant human keratinocyte growth factor (rHuKGF) in reducing severe oral mucositis induced by total body irradiation and high dose chemotherapy in patients with hematologic malignancies. II. Compare the incidence of severe oral mucositis, the use of transdermal or perenteral opioid analgesics, and the incidence and duration of grade 2-4 diarrhea with or without rHuKGF in these patients. III.
Determine the quality of life of these patients. IV. Determine the duration of febrile neutropenia and the duration of treatment with intravenous antifungals or antibiotics in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center. Patients are randomized to one of three treatment arms. Arm I: Patients receive recombinant human keratinocyte growth factor (rHuKGF) IV on days -11 to -9, -5, and 0 to 2. Total body irradiation (TBI) is administered twice a day on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2 (some patients may receive an alternate regimen of ifosfamide IV over 1 hour on days-4 to 0 followed each day by etoposide IV over 23 hours). Filgrastim (G-CSF) is administered subcutaneously (SQ) beginning on day 0 and continuing for up to 21 days until blood counts recover. Autologous peripheral blood stem cells (PBSC) are infused on day 0. Arm II: Patients receive rHuKGF on days -11 to -9 and -5 as in arm I. Placebo is administered on days 0 to 2. TBI, chemotherapy, and PBSC transplantation are administered as in arm I. Arm III: Patients receive placebo on days -11 to -9, -5, and 0 to 2. TBI, chemotherapy, and PBSC transplantation are administered as in arm I. Quality of life is assessed prior to treatment, daily during therapy and until day 28 after transplantation. Patients are followed at day 28 and approximately day 60-100.
PROJECTED ACCRUAL: At least 111 patients (37 per arm) will be accrued for this study within 15 months.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of one of the following: Non-Hodgkin's lymphoma Hodgkin's disease Acute myelogenous leukemia Acute lymphoblastic leukemia Chronic myelogenous leukemia Chronic lymphocytic leukemia Eligible for fractionated total body irradiation plus high dose chemotherapy followed by autologous peripheral blood stem cell support No prior entry into this study
PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnofsky 70-100% SWOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: DLCO at least 60% predicted Other: No other prior or concurrent malignancy No active infection or oral mucositis No diabetes mellitus requiring insulin HIV negative No sensitivity to E. coli derived products Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone marrow or peripheral blood stem cell transplantation No concurrent interleukin-11 Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior extensive radiotherapy that would preclude study irradiation Surgery: Not specified Other: At least 30 days since prior investigational study No other concurrent investigational agents No concurrent prophylactic oral cryotherapy during study chemotherapy
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Eric W. Hedrick, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000067261, MSKCC-99029, AMGEN-KGF-980231-04, NCI-G99-1574 |
| Study First Received: | December 10, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004061 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic 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 meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission oral complications stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma |
|
Blast Crisis Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Mitogens Hodgkin Disease Etoposide Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia, Myeloid |
B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Immunologic Factors Hematologic Neoplasms Lymphoma, Follicular Quality of Life Lymphoma, B-Cell, Marginal Zone Leukemia, Myeloid, Chronic-Phase Cyclophosphamide Leukemia, Myeloid, Acute Lymphoblastic Lymphoma Etoposide phosphate |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Leukemia Lymphatic Diseases |
Neoplasms Ifosfamide Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Lymphoma |
