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Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

Primary Purpose

Radiation-induced Dermatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ST266
Sponsored by
Noveome Biotherapeutics, formerly Stemnion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation-induced Dermatitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ST266 intact

ST266 inflamed

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adverse Events (AEs) and Significant Adverse Events (SAEs)

Secondary Outcome Measures

Skin inflammation
Quality of Life (QOL)scaled responses
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.

Full Information

First Posted
October 16, 2012
Last Updated
May 9, 2019
Sponsor
Noveome Biotherapeutics, formerly Stemnion
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1. Study Identification

Unique Protocol Identification Number
NCT01714973
Brief Title
Study of ST266 Versus Saline in Treating Skin Irritation From Radiation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noveome Biotherapeutics, formerly Stemnion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-induced Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ST266 intact
Arm Type
Experimental
Arm Description
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.
Arm Title
ST266 inflamed
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ST266
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events (AEs) and Significant Adverse Events (SAEs)
Time Frame
Start of therapy through six week follow-up visit
Secondary Outcome Measure Information:
Title
Skin inflammation
Time Frame
start of therapy through six week follow-up visit
Title
Quality of Life (QOL)scaled responses
Description
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.
Time Frame
start of therapy through one year follow-up
Other Pre-specified Outcome Measures:
Title
Cosmesis
Description
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.
Time Frame
6 and 12 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Trombetta, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David L Steed, MD
Organizational Affiliation
Noveome Biotherapeutics, formerly Stemnion
Official's Role
Study Director
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

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