Phase I/II Study of Escalating-Dose Melphalan w/Autologous SCS & Amifostine Cytoprotect
Condition: Breast Cancer; Leukemia; Lymphoma; Neuroblastoma; Ovarian Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Breast Neoplasms; Leukemia; Sarcoma; Neuroblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
      Chemoprotective drugs such as amifostine may protect normal cells from the side effects of
      chemotherapy.

      PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral
      stem cell transplantation and amifostine in treating patients with cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous
      peripheral blood stem cell support and amifostine cytoprotection in patients with cancer. II.
      Determine the complete response rate, event free survival, overall survival, and nonrelapse
      mortality in this patient population.

      OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and
      amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is
      given until cytapheresis is completed. Patients receive high dose melphalan according to an
      escalating dose schedule. High dose melphalan is administered IV on day -1. Amifostine is
      also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed
      on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients
      experience dose limiting toxicity. After the MTD of high dose melphalan is determined,
      additional patients are treated at this dose level. Patients are followed at days 30, 100,
      365, and yearly thereafter.

      PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued
      for this study.
    

Intervention name(s): filgrastim; amifostine trihydrate; cyclophosphamide; melphalan; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Procedure
Other intervention name(s): WR-2721
Intervention MeSH terms: Cyclophosphamide; Melphalan; Amifostine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; recurrent adult Hodgkin lymphoma; refractory multiple myeloma; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; regional neuroblastoma; disseminated neuroblastoma; stage 4S neuroblastoma; recurrent neuroblastoma; stage III multiple myeloma; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; unspecified adult solid tumor, protocol specific; untreated adult acute lymphoblastic leukemia; untreated adult acute myeloid leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; ovarian stromal cancer; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor; acute undifferentiated leukemia; 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; borderline ovarian surface epithelial-stromal tumor; ovarian sarcoma; localized unresectable neuroblastoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma