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
18 Years
65 Years
Both
Leukemia, Lymphoma, Oral Complications
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Eric W. Hedrick, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
AMGEN-KGF-980231-04
NCT ID:
NCT00004061
Start Date:
May 1999
Completion Date:
December 2009
Related Keywords:
- Leukemia
- Lymphoma
- Oral Complications
- 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
- stage I adult lymphoblastic lymphoma
- stage I adult Burkitt lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt 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
- secondary acute myeloid leukemia
- stage I mantle cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
