amifostine followed by high dose chemotherapy in treating patients with hematologic cancer or solid tumors

Conditions: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Lymphoma; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility criteria:
disease characteristics: histologically confirmed hematologic malignancies and adult solid tumors, including: non-hodgkin's lymphoma lung cancer hodgkin's disease ovarian cancer breast cancer no refractory disease (less than partial response to induction chemotherapy) no cns metastases no unilateral bone marrow biopsy within 6 months of study showing at least 20% involvement by fibrosis tumors hormone receptor status: not specified patient characteristics: age: 18 to 70 menopausal status: not specified performance status: ecog 0-2 life expectancy: at least 16 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: sgot or sgpt no greater than 2.5 times upper limit of normal renal: creatinine no greater than 2 mg/dl other: hiv negative not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no underlying medical or psychiatric conditions no concurrent active infection no prior malignancies except nonmelanoma skin cancer prior concurrent therapy: biologic therapy: at least 4 weeks since prior myeloid growth factor chemotherapy: at least 4 weeks since prior chemotherapy no more than 1 prior chemotherapy regimen (excluding adjuvant chemotherapy) endocrine therapy: not specified radiotherapy: at least 4 weeks since pelvic, para-aortic, inverted y, cranial, spinal, or mediastinal radiation surgery: at least 2 weeks since major surgery other: no antihypertensive medication within 24 hours of amifostine administration

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