Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase IV | Supportive care | Completed | 18 and over | Pharmaceutical / Industry | RNSMC-AM9702 ALZA-RNSMC-AM9702, NCI-V98-1390, NCT00003252 |
Objectives
I. Determine the feasibility and tolerability of administering amifostine by intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy.
Entry Criteria
Disease Characteristics:
Histologically or cytologically proven cancer No brain or other CNS metastases (including prior treated metastases)
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
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
Expected Enrollment
A total of 20 patients will be accrued for this study.
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.
Trial Lead Organizations
Rush North Shore Medical Center
 | | | ||
| Edward Kaplan, MD, Protocol chair | |
| ||
| ||||
| Registry Information | ||
| ||
| Official Title | A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol (Amifostine) in Patients Undergoing Chemotherapy | |
| ||
| Trial Start Date | 1997-12-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00003252 | |
| ||
| Date Submitted to PDQ | 1998-03-06 | |
| ||
| Information Last Verified | 2000-04-01 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Back to Top
