Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

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

Sponsors

Lead Sponsor: Noveome Biotherapeutics, formerly Stemnion

Source Noveome Biotherapeutics, formerly Stemnion
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.

Overall Status Completed
Start Date October 2012
Completion Date October 2015
Primary Completion Date July 2015
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse Events (AEs) and Significant Adverse Events (SAEs) Start of therapy through six week follow-up visit
Secondary Outcome
Measure Time Frame
Skin inflammation start of therapy through six week follow-up visit
Quality of Life (QOL)scaled responses start of therapy through one year follow-up
Enrollment 20
Condition
Intervention

Intervention Type: Biological

Intervention Name: ST266

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.

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Allegheny General Hospital
Location Countries

United States

Verification Date

May 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: ST266 intact

Type: Experimental

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.

Label: ST266 inflamed

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov