Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
Condition: Drug/Agent Toxicity by Tissue/Organ; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Oral Complications; Radiation Toxicity
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

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.
    

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.
      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.
    

Intervention name(s): filgrastim; palifermin; cyclophosphamide; etoposide; ifosfamide; quality-of-life assessment; radiation therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Ifosfamide; Etoposide
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: 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