Overview

Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity

Status:
Active, not recruiting
Trial end date:
2021-04-15
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc (CIZ) in a multivitamin combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated squamous cell carcinoma of the oral cavity or soft palate at a median of 3 years
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CEL-SCI Corporation
Collaborators:
Orient Europharma Co., Ltd.
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Pharmaceutical Industries
Treatments:
Cisplatin
Cyclophosphamide
Indomethacin
Criteria
Inclusion Criteria:

- Untreated SCCHN of oral cavity/soft palate, categories
T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is
negligible) scheduled for SOC

- Primary tumor and any positive node(s)measurable in 2 dimensions

- normal immune function

- no immunosuppressives with 1 year

- KPS>70

- Age>18

- Male or Female (non-pregnant)

- Life expectancy >6mo.

- Able to take oral medication

- Able to provide informed consent

Exclusion Criteria:

- Subjects to be treated with other than SOC

- Tumor invasion of bone (also see inclusion criteria)

- Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1

- Tumors in locations other than those specified in inclusion criteria

- Active peptic ulcer

- Prior resection of jugular nodes ipsilateral to tumor

- Acute or chronic viral, bacterial immune or other disease associated with abnormal
immune function

- Subjects on hemodialysis or peritoneal dialysis

- History of asthma

- Any condition that in the opinion of the investigator would cause the subject to be
unable to participate or tolerate the protocol regimen