Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

NCT01714973 | Completed Phase 1 DMC

• 1 other identifier: ST-02-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-induced Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  Start of therapy through six week follow-up visit

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Cosmesis

  6 and 12 months post-treatment

Study Arms (2)

ST266 intact

EXPERIMENTAL

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.

Biological: ST266

ST266 inflamed

EXPERIMENTAL

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.

Biological: ST266

Interventions

ST266 BIOLOGICAL

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.

ST266 inflamed; ST266 intact

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Mark Trombetta, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

• David L Steed, MD

  Noveome Biotherapeutics, formerly Stemnion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)