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Subcutaneous Amifostine Safety Study

Primary Purpose

Head and Neck Cancer, Lung Cancer, Lymphoma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Amifostine administered subcutaneously

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring Amifostine, Mucositis, Nausea, Hypotension, Rash

Eligibility Criteria

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

Sites / Locations

Mt. Sinai Medical Center

Outcomes

Primary Outcome Measures

Incidence of nausea/vomiting

Incidence of hypotension

Incidence of generalized skin rash

Incidence of injection-site skin toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00158041

First Posted

September 7, 2005

Last Updated

September 7, 2005

Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT00158041

Brief Title

Subcutaneous Amifostine Safety Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

January 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

MedImmune LLC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Head and Neck Cancer, Lung Cancer, Lymphoma

Keywords

Amifostine, Mucositis, Nausea, Hypotension, Rash

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

452 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amifostine administered subcutaneously

Primary Outcome Measure Information:

Title

Incidence of nausea/vomiting

Title

Incidence of hypotension

Title

Incidence of generalized skin rash

Title

Incidence of injection-site skin toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Samuels, MD

Organizational Affiliation

Mt. Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mt. Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Subcutaneous Amifostine Safety Study

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