Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Subcutaneous Amifostine Safety Study
Sponsors
Source
Mt. Sinai Medical Center, Miami
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.
Overall Status
Completed
Start Date
2002-01-01
Completion Date
2005-01-01
Primary Completion Date
N/A
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
|
Incidence of nausea/vomiting |
|
Incidence of hypotension |
|
Incidence of generalized skin rash |
|
Incidence of injection-site skin toxicity |
Enrollment
452
Conditions
Intervention
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Michael A Samuels, MD |
Principal Investigator |
Mt. Sinai Medical Center |
Location
Facility |
|
Mt. Sinai Medical Center Miami Beach Florida 33140 United States |
Location Countries
Country
United States
Verification Date
2005-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Amifostine
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Study First Submitted
September 7, 2005
Study First Submitted Qc
September 7, 2005
Study First Posted
September 12, 2005
Last Update Submitted
September 7, 2005
Last Update Submitted Qc
September 7, 2005
Last Update Posted
September 12, 2005
ClinicalTrials.gov processed this data on August 22, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.