Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
Condition: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Lymphoma; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Breast Neoplasms; Lung Neoplasms; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells
      from the side effects of chemotherapy.

      PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by
      high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of amifostine in enhancing hematopoietic recovery
      following cyclophosphamide, etoposide, and cisplatin therapy in patients with hematologic
      malignancies and adult solid tumors.

      OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes
      daily 30 minutes prior to high dose chemotherapy on days 0-2. Cyclophosphamide is
      administered over 3 hours on days 0 and 1, intravenous etoposide over 4 hours on days 0, 1,
      and 2, and cisplatin over 4 hours on days 0, 1, and 2. All patients receive sargramostim
      (GM-CSF) beginning on day 4. Patients receive a maximum of 2 courses of treatment (with 35-42
      days between chemotherapy courses). Patients are followed for 1-5 months after treatment.

      PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12 months.
    

Intervention name(s): sargramostim; amifostine trihydrate; cisplatin; cyclophosphamide; etoposide
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Etoposide; Sargramostim; Amifostine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
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; stage I breast cancer; stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIB breast cancer; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; Waldenstrom macroglobulinemia; limited stage small cell lung cancer; extensive stage small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; unspecified adult solid tumor, protocol specific; 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; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; drug/agent toxicity by tissue/organ; 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; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone 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