NCT00158041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for phase_4 head-and-neck-cancer

Timeline
Completed

Started Jan 2002

Typical duration for phase_4 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

September 7, 2005

Conditions

Head and Neck CancerLung CancerLymphoma

Keywords

AmifostineMucositisNauseaHypotensionRash

Outcome Measures

Primary Outcomes (4)

  • Incidence of nausea/vomiting

  • Incidence of hypotension

  • Incidence of generalized skin rash

  • Incidence of injection-site skin toxicity

Interventions

Amifostine administered subcutaneouslyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Allergy to amifostine
  • Life expectancy less than 6 mos
  • Investigational drug within last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLung NeoplasmsLymphomaMucositisNauseaHypotensionExanthema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael A Samuels, MD

    Mt. Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

January 1, 2002

Study Completion

January 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

US(1)