Subcutaneous Amifostine Safety Study | NCT00158041

Studies
Subcutaneous Amifostine Safety Study

NCT00158041

Sponsor

Mt. Sinai Medical Center, Miami

Status

Completed

Last Update Posted

Sep 12, 2005Estimated

Enrollment

452

Phase

Phase 4

Conditions

Head and Neck Cancer
Lung Cancer
Lymphoma

Interventions

Amifostine administered subcutaneously

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Jan 2005

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2005

Last Update Posted Date

Sep 12, 2005Estimated

Name	Class
MedImmune LLC	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

452

Name	Type	Description	Arm Group Labels	Other Names
Amifostine administered subcutaneously	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of nausea/vomiting
Incidence of hypotension
Incidence of generalized skin rash
Incidence of injection-site skin toxicity

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael A Samuels, MD	Mt. Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mt. Sinai Medical Center		Miami Beach	Florida	33140	United States

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D008175	Lung Neoplasms
D008223	Lymphoma
D052016	Mucositis
D009325	Nausea
D007022	Hypotension
D005076	Exanthema

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided