Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

Noveome Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Radiation-induced Dermatitis

Treatments: Biological: ST266

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714973

ST-02-12

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

ST266 intact

Experimental group

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.

Treatment:

Biological: ST266

ST266 inflamed

Experimental group

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.

Treatment:

Biological: ST266