A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV‑07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy.
||Kenneth Hu, MD
| Time frame of study:
|Location of Study:
Beth Israel Medical Center
St.Luke's-Roosevelt Hospital Center
Continuum Cancer Research Program
This study involves treatment with an experimental drug called SCV-07. SCV-07 is an investigational drug that is being tested to treat mouth pain and ulcers, which may be caused by your cancer treatment.
In the United States, SCV-07 has been tested in humans as an injection, as a pill you swallow, and as a solution absorbed under the tongue. However, the best adsorption of the drug occurs when it is injected under the skin (subcutaneous (sc) injections). SCV-07 may increase your immune system activity and may have positive effects while you fight infections and respond to the prescribed treatment.
The main purpose of this study is to see how safe, how well-tolerated, and how effective SCV-07 is in subjects with head and neck cancer who have Oral Mucositis (mouth sores). Other goals of this study are to decide the most effective dose of SCV-07 that would shorten the length of time that you have mouth sores and decrease the severity of OM.
- Age 18 and older
- subject with Squamous cell cancers of the head and who have undergone concurrent chemoradiation (chemotherapy and radiation at the same time) and neck dissection
- No prior radiation therapy to the head and neck.
- Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor are exclusions.
- Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential.
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