Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer

NCT ID: NCT00004061

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Leukemia; Lymphoma; Oral Complications

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

filgrastim

Intervention Type: BIOLOGICAL

palifermin

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Eric W. Hedrick, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-99029

Identifier Type: -

Identifier Source: secondary_id

CDR0000067261

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G99-1574

Identifier Type: -

Identifier Source: secondary_id

AMGEN-KGF-980231-04

Identifier Type: -

Identifier Source: org_study_id