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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


Phase 2
12 Years
65 Years
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Oral Complications, Radiation Toxicity

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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 Progenitor Cell (PBPC) Transplantation


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.
IV. 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

AMGEN-KGF-980231-03

NCT ID:

NCT00004132

Start Date:

January 2000

Completion Date:

May 2004

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Oral Complications
  • Radiation Toxicity
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • childhood Burkitt lymphoma
  • refractory multiple myeloma
  • stage 0 chronic lymphocytic leukemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage IV childhood lymphoblastic lymphoma
  • 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
  • refractory chronic lymphocytic leukemia
  • blastic phase chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood acute lymphoblastic leukemia
  • oral complications
  • stage IV childhood Hodgkin lymphoma
  • 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
  • primary central nervous system non-Hodgkin lymphoma
  • drug/agent toxicity by tissue/organ
  • radiation toxicity
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • 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
  • anaplastic large 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
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Lymphoma, Large-Cell, Immunoblastic
  • Radiation Injuries

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781