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Subcutaneous Amifostine Safety Study | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Subcutaneous Amifostine Safety Study

Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

NCT00158041•Mt. Sinai Medical Center, Miami

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Mt. Sinai Medical Center

Miami Beach, Florida, United States

Key Dates

Start Date

January 1, 2002

Completion Date

January 1, 2005

Last Updated

September 12, 2005

Enrollment

452

Estimated participants

Conditions

Head and Neck CancerLung CancerLymphoma

Interventions

Amifostine administered subcutaneously

DRUG

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

NCT05198830

Lung AdenocarcinomaLung Large Cell Carcinoma+2 more

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RECRUITINGPHASE2

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Subcutaneous Amifostine Safety Study

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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