Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy

Rush North Shore Medical Center

Status and phase: Completed; Phase 4

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Drug/Agent Toxicity by Tissue/Organ

Treatments: Drug: amifostine trihydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00003252

RNSMC-AM9702

CDR0000066134

NCI-V98-1390

ALZA-RNSMC-AM9702

Details and patient eligibility

About

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: Phase IV trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy.

Full description

OBJECTIVES: I. Determine the feasibility and tolerability of administering amifostine by intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy.

OUTLINE: This is an open label, controlled study. Patients receive intravenous amifostine over 5 minutes 30 minutes prior to chemotherapy. Patients are followed for one month post treatment.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven cancer No brain or other CNS metastases (including prior treated metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: No grade 3 or greater hepatic dysfunction Renal: No hypercalcemia Cardiovascular: No uncontrolled hypotension Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No psychosis No severe concurrent illness other than neoplasia No epileptic seizures during the previous year, migraines, gastrointestinal obstructions, or other causes of vomiting No prior or concurrent amifostine contraindications No prior known contraindications or sensitivity to dexamethasone, granisetron, ondansetron, prochlorperazine, diphenhydramine, cimetidine, or magnesium

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior estrogen within 24 hours of amifostine therapy Radiotherapy: Not specified Surgery: Not specified Other: No prior alcohol, disulphiram, tetracycline, or erythromycin within 24 hours of amifostine therapy No prior antiemetics such as benzodiazepines, antipsychotics, anticonvulsants, or antihistamines within 24 hours of amifostine therapy