- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01714973
Study of ST266 Versus Saline in Treating Skin Irritation From Radiation
May 9, 2019 updated by: Noveome Biotherapeutics, formerly Stemnion
Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor
The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- A signed IRB - approved Informed Consent;
- Women 18 - 80 years of age;
- Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.
- Whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist.
- If a woman is of child-bearing potential, she and her partner must use an effective form of birth control.
- Willing to participate in the clinical study and comply with the requirements of the trial.
Exclusion Criteria:
- Abnormal liver or kidney function studies being greater than 2x the upper limit of normal.
- Patients on hemodialysis
- Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
- History of non-compliance with treatment or clinical visit attendance.
- Participation in an investigational trial within 30 days of study entry.
- Women who are pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ST266 intact
Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment.
The area of the breast will be divided into two, roughly equal parts, medial and lateral.
The randomization scheme will be equal in each of two cohorts.
The first cohort will receive ST266 and saline placebo applied to intact skin beginning immediately following the first radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
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Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments.
ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.
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Experimental: ST266 inflamed
Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment.
The area of the breast will be divided into two, roughly equal parts, medial and lateral.
The randomization scheme will be equal in each of two cohorts.
The second cohort will receive ST266 and saline placebo applied to inflamed skin (after inflammation is first noted) beginning immediately following the radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
|
Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments.
ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events (AEs) and Significant Adverse Events (SAEs)
Time Frame: Start of therapy through six week follow-up visit
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Start of therapy through six week follow-up visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin inflammation
Time Frame: start of therapy through six week follow-up visit
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start of therapy through six week follow-up visit
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Quality of Life (QOL)scaled responses
Time Frame: start of therapy through one year follow-up
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Quality of Life (QOL) will be evaluated using a QOL Assessment (general to breast cancer patients receiving radiation therapy following tumor removal) and a QOL Supplement (specific to subjects receiving trial treatment).
Both documents include subsets of questions, each with a different subscale.
The assessments include both lifestyle QOL factors (sleep, activity, friends/family, general life enjoyment, etc.) and breast condition (pain, appearance, ect.).
This secondary endpoint will focus on the QOL Supplement, comparing breast condition by treatment, noting changes in both the medial and lateral aspects breast including breast texture (thickening and hardness), pain, tenderness, shape, sensitivity, swelling, redness, itching, flaking skin, blistering and fluid leak.
The patient will note, for each item, in which side of the breast they are experiencing the negative breast condition or if there is no difference.
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start of therapy through one year follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmesis
Time Frame: 6 and 12 months post-treatment
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Cosmesis will be evaluated by photography and investigator assessment using the cosmesis form in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-39, A Randomized Phase III Study of Conventional Whole Breast Irradiation Versus Partial Breast Irradiation for Women with Stage 0, I, or II Breast Cancer.
The following factors will be evaluated in the skin: telangiectasia, atrophy, scarring, pigmentation, erythema, fat necrosis, and fibrosis.
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6 and 12 months post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: David L Steed, MD, Noveome Biotherapeutics, formerly Stemnion
- Principal Investigator: Mark Trombetta, MD, West Penn Allegheny Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 16, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (Estimate)
October 26, 2012
Study Record Updates
Last Update Posted (Actual)
May 13, 2019
Last Update Submitted That Met QC Criteria
May 9, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-02-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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