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.

Condition	Treatment or Intervention	Phase
Lung Cancer Ovarian Cancer Lymphoma Leukemia Breast Cancer	Drug: amifostine  Drug: cisplatin  Drug: cyclophosphamide  Drug: etoposide  Drug: sargramostim	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

California
      Scripps Clinic, La Jolla,  California,  92037,  United States

Study chairs or principal investigators

James Ronald Mason,  Study Chair,  Scripps Clinic   

Study ID Numbers:  CDR0000066165; SCRF-98014; NCI-V98-1396; ALZA-97-49-ii
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003269
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08