Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 24
• Participant gender: Both

Summary

This is a Phase 1, two part, study of patients with recurrent Head and Neck Cancer (HNC), who in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. Part I is a drug dose-escalation, fixed low fluency light application study to determine the drug dose that can be safely given to saturate the epidermal growth factor receptor (EGFR) at the tumor.

Part II is a light treatment dose-escalation, fixed drug dosing infusion study to determine the optimal light application, in combination with the Part I drug dose, needed to achieve clinical response with an acceptable safety profile.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aspyrian Therapeutics, Inc.
• Last Updated: 2016-11-09

Criteria

Inclusion Criteria:

1. Patients with recurrent squamous carcinoma of the Head and Neck, who in the opinion of their treating physician, cannot be satisfactorily treated with surgery, radiation, or platinum chemotherapy. Diagnosis must be confirmed by biopsy and histopathology.

2. Patient must have received prior systemic platinum-based chemotherapy for treatment of their head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended, e.g., renal impairment, allergy to platinum compounds, age, liver disease, myelosuppression, neuropathy, hearing loss, etc.

3. Patients must have life expectancy > 6 months based on investigator judgment.

4. Male or female patients at least 18 years old. Female patients must not be pregnant or breast feeding and must be practicing a medically acceptable form of birth control, be sterile, or post-menopausal. Females of childbearing potential (FCBP) is defined as premenopausal women capable of becoming pregnant. This includes women who are post-menopausal for at least 12 months after the last menses. FCBP must agree to use a medically acceptable form of birth control during the study and for at least 6 months after discontinuation of Erbitux® or study medication. Females must agree not to breast feed during the study and for at least two months after discontinuation of Erbitux® or study medication. Male patients should be using a double barrier protection method that is a medically acceptable form of birth control during the study or be sterile.

5. Patients must have an ECOG score of 0 - 2.

6. Patient must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

1. Patients with a history of significant Erbitux infusion reactions (≥ Grade 3).

2. Patients on chemotherapy or Erbitux® therapy or radiation therapy within 4 weeks of enrollment.

3. Tumor invading a major blood vessel (such as the carotid artery) unless the vessel has been embolized, stented or surgically ligated to prevent hemorrhage.

4. Tumor is not clearly shown on a CT scan or clinically measurable.

5. Location and extension of the tumor precludes an effective PIT.

6. Patients with impaired hepatic function (ALP (hepatic), AST and/or ALT >3 times the upper normal limits, or total serum bilirubin > 2 mg/dL.

7. Patients with impairment of renal function (serum creatinine >2 mg/dL).

8. Unwilling or unable to follow protocol requirements.

9. Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug.

10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

11. Patient requires examinations or treatments within 4 weeks after study drug administration where they would be exposed to significant light, e.g., eye examinations, surgical procedures, endoscopy, etc.