This section is intended for patients already participating in or interested in participating in the ongoing Phase III clinical trial of our investigational therapy MultikineŽ (Leukocyte Interleukin, Injection). Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
Clinical trials are voluntary research studies, conducted in people (human subject volunteers) that are designed to answer specific questions about the safety and/or effectiveness of new and existing drugs, vaccines, other therapies, or new ways of using new or existing treatment regimens. To obtain additional general information about clinical trials, you can read more at http://www.fda.gov. and http://www.clinialtrials.gov.
CEL-SCI's lead investigational therapy, Multikine, is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. Multikine has been cleared by regulators in 9 countries, including the United States, for study in a global Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients. This trial is expected to be the largest head and neck cancer clinical study ever conducted.
The study will enroll approximately 880 subjects with previously untreated advanced primary head and neck cancer worldwide. The Phase III open-label, randomized, controlled, multi-center study will be conducted in about 48 centers in 9 countries and on 3 continents. The intent of the study is to develop data on the efficacy and safety of Multikine in treating head and neck cancer. Read more about this trial here or at http://www.clinicaltrials.gov.
The Multikine Phase III trial is referred to as the "IT-MATTERS" trial. "IT-MATTERS" is an acronym for Immuno-Therapy Multikine Anti Tumor Treatments. The investigational therapy is given to patients right after diagnosis, ahead of surgery or any other treatments, because CEL-SCI believes that, in order for immunotherapy to have the greatest potential to achieve its effect, it must be given to patients before their lymphatics (the "highways" of the immune cells) are damaged during surgery and before the weakening of the immune system often seen following radiation and chemotherapy. Consequently, if you already have undergone surgery, or any other treatment for your head and neck cancer, you will definitely not be eligible for the current IT-MATTERS Phase III clinical trial.
Study Summary: A Pivotal Phase III, Open-label, Randomized, Controlled, Multi-center Global Study of the Effects of Multikine Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity and Soft Palate Versus Standard of Care Only. Advanced primary (not yet treated) head and neck cancer represents an unmet medical need with minimal progress in the 5-year survival rate despite advances in cancer treatments over the last 30-50 years.
Objectives: As set forth in the study protocol, the primary objective of this Phase III trial is to evaluate the efficacy of peri-tumoral and peri-lymphatic injection of the investigational Multikine therapy given prior to Standard of Care (SOC) (as currently defined by the NCCN Guidelines). This will be evaluated based upon measurements of overall survival. The secondary objectives are to evaluate the effects of the investigational Multikine therapy on the cumulative incidence of local-regional control, progression-free survival, tumor histopathology, and quality of life, while also seeking to confirm Multikine safety and assessing tumor response.
The Phase III trial is designed to compare the investigational Multikine therapy combined with the current standard of care (SOC) therapy for head and neck cancer patients (as currently defined by the NCCN Guidelines) vs. the SOC therapy alone in advanced primary Head and Neck cancer patients. The current SOC therapy for head and neck cancer (as defined in the NCCN Guidelines, published by the National Comprehensive Cancer Network) is surgery, followed by radiation, or surgery followed by radiation and concurrent chemotherapy (for patients considered to be at higher risk for recurrence). Every patient in this Phase III study will receive, at least, the current SOC therapy treatment regimen.
Subject to completion of CEL-SCI's well-controlled, global Phase III clinical trial and FDA's review of our entire data set on this investigational therapy, if FDA were to conclude that the safety and efficacy of this investigational therapy is established, the early-phase clinical data is encouraging in suggesting the potential that approximately 60-66% (2/3) of head and neck cancer patients who present with advanced primary disease could be candidates for this therapy if it is approved for marketing by FDA.
This Phase III study is also the first study in the world in which immunotherapy is given to patients first, i.e., prior to receiving any conventional treatment for cancer, including surgery, radiation and/or chemotherapy. This could be shown to be important because conventional therapy may weaken the immune system, and may compromise the potential effect of immunotherapy. Published data on the investigational Multikine therapy studied in animals (Chirigos et al Immunopharm. and Immunotox. 1995) and in humans (Timar et al JCO 2005) indicates that it appears to work by activating the intact local anti-tumor immune system since it is given before conventional cancer therapy.
This protocol is currently RECRUITING. If you would like more information about this study, please contact CEL-SCI at:
Clinical Studies Project Manager
8229 Boone Boulevard, Suite 802
Vienna, VA 22182, USA
Telephone USA (703) 506-9460
We will be able to assess if a study center is near you.
Number of Subjects: 880
Clinical Centers: approximately 48 globally distributed; North America, Europe, Asia
Statistics: 80% Power; 95% confidence - to show a 10% Overall Survival advantage
Age: > 18 Y.O.
Genders eligible for study: Male and female
Main 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 within 1 year
- Male or Female (if female, not pregnant)
- Life expectancy >6mo.
- Able to take oral medication
- Able to provide informed consent
Main Exclusion Criteria:
- Subjects to be treated with other than SOC
- Tumor invasion of bone
- 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
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.