Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004132

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.

Condition or Disease	Intervention/Treatment	Phase
Drug/Agent Toxicity by Tissue/Organ Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Oral Complications Radiation Toxicity	Biological: filgrastim Biological: palifermin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Procedure: quality-of-life assessment Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES: I. Determine the efficacy of recombinant keratinocyte growth factor in reducing the duration of severe oral mucositis induced by total body irradiation and high dose chemotherapy in patients with hematologic malignancies. II. Determine the incidence and duration of severe oral mucositis, grade 2-4 diarrhea, and febrile neutropenia in these patients. III. Determine the necessity of use of transdermal or parenteral opioid analgesics and IV antifungals or antibiotics for febrile neutropenia or infections in these patients.

Determine the quality of life of these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified by center. Patients are randomized to one of three treatment arms. Arm I:

Patients receive 7 doses of recombinant human keratinocyte growth factor (rHuKGF). Arm II:

Patients receive 4 doses of rHuKGF followed by 3 doses of placebo. Arm III: Patients receive 7 doses of placebo. Patients receive one of two conditioning regimens. Primary conditioning regimen: Patients receive rHuKGF or placebo daily on days -11, -10, -9, -5, 0, 1, and 2. Total body irradiation (TBI) is administered twice a day on days -8 to -5. Patients receive etoposide on day -4, cyclophosphamide IV over 1 hour on day -2, and peripheral blood stem cell transplantation (PBSCT) on day 0. Filgrastim (G-CSF) IV or SC is administered beginning on day 0 and continuing for 21 days or until blood counts recover. Secondary conditioning regimen: Patients receive rHuKGF or placebo daily on days -13, -12, -11, -7, 0, 1, and 2. TBI is administered twice a day on days -10 to -7. Patients receive ifosfamide IV over 1 hour followed by etoposide over 23 hours on days -6 to -2, then PBSCT on day 0. G-CSF IV or SC is administered beginning on day 0 for 21 days or until blood counts recover. Quality of life is assessed daily beginning on day -11 and continuing until day 28. Patients are followed at day 28 and then at day 60-100.

PROJECTED ACCRUAL: A minimum of 111 patients (37 per arm) will be accrued for this study.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Supportive Care

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 Progenitor Cell (PBPC) Transplantation

Study Start Date :

Jan 1, 2000

Actual Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Diagnosis of Non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma Eligible for total body irradiation plus high dose chemotherapy followed by autologous peripheral blood stem cell transplantation At least 1,500,000 CD34+ cells/kg cryopreserved No prior treatment on this study

PATIENT CHARACTERISTICS: Age: 12 to 65 Performance status: Karnofsky 70-100% SWOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1000/mm3 Platelet count greater than 100,000/mm3 If conditioning regimen scheduled soon after apheresis, platelet count of greater than 50,000/mm3 but less than 100,000/mm3 allowed Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No congestive heart failure No New York Heart Association class III or IV heart disease Pulmonary: DLCO at least 50% predicted Other: No prior or concurrent second malignancy No active infection or oral mucositis No insulin dependent diabetes mellitus HIV negative No sensitivity to E. coli derived products Not pregnant or nursing Fertile patients must use effective contraception one month before, during, and one month after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem cell transplantation, unless undergoing second transplant of a tandem transplant regimen, with no complications after first transplant No concurrent interleukin-11 Chemotherapy: No other concurrent cytotoxic chemotherapy, except intrathecal methotrexate for CNS involvement Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy that would preclude total body irradiation Surgery: Not specified Other: At least 30 days since prior investigational devices or drugs, except Baxter Isolex i column No other concurrent investigational agents No concurrent prophylactic oral cryotherapy during chemotherapy