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Subcutaneous Amifostine Safety Study

NCT ID: NCT00158041

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-01-31

Brief Summary

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Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Detailed Description

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Conditions

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Head and Neck Cancer Lung Cancer Lymphoma

Keywords

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Amifostine Mucositis Nausea Hypotension Rash

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Amifostine administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Institutional criteria for administration of amifostine
* Radiation therapy
* ECOG PS of at least 2
* No distant mets
* Granulocyte count greater than 2000
* Platelet count greater than 100,000
* Creatinine less than 2.0

Exclusion Criteria

* Allergy to amifostine
* Life expectancy less than 6 mos
* Investigational drug within last 4 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role collaborator

Mt. Sinai Medical Center, Miami

OTHER

Sponsor Role lead

Principal Investigators

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Michael A Samuels, MD

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai Medical Center

Locations

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Mt. Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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ETH056-01D

Identifier Type: -

Identifier Source: org_study_id