Overview

Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Scripps Health
Treatments:
Amifostine
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Sargramostim
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