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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

amifostine trihydrate

About this trial

This is an interventional supportive care trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring unspecified adult solid tumor, protocol specific, drug/agent toxicity by tissue/organ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rush North Shore Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003252

First Posted

November 1, 1999

Last Updated

March 25, 2013

Sponsor

Rush North Shore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00003252

Brief Title

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

Official Title

A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol (Amifostine) in Patients Undergoing Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2000

Overall Recruitment Status

Completed

Study Start Date

December 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rush North Shore Medical Center

4. Oversight

5. Study Description

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

unspecified adult solid tumor, protocol specific, drug/agent toxicity by tissue/organ

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

amifostine trihydrate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward H. Kaplan, MD

Organizational Affiliation

Rush North Shore Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Rush North Shore Medical Center

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

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

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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