Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck (HNC)
The purpose of this study is to determine the safety and tolerability of personalized anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who cannot be treated with surgery, chemotherapy or radiation. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of CRCL and AlloStim(TM) is designed to provide all the key components necessary to develop tumor-specific immunity creating the inflammatory environment necessary to overcome the HNC immunosuppressive environment, breaking tumor immune tolerance, and provision of specific HNC antigens for generation of a specific adaptive anti-tumor response.
Cancer of Head and Neck
Squamous Cell Carcinoma of the Head and Neck
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase I/II, Randomized Double-Blinded, Placebo-Controlled Study Designed To Evaluate Safety, Tolerability of an Individualized Cancer Vaccine (AllovaxTM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck.|
- To compare the safety and tolerability of AlloVax to the placebo [ Time Frame: From start of the treatment to 30 days after the last dose (it will be 5 months) ] [ Designated as safety issue: Yes ]Safety and tolerability will be evaluated by physical exam, changes in laboratory values and patient reported symptoms.
- Anti-tumor specific immune response [ Time Frame: 30 days after the last dose ] [ Designated as safety issue: No ]To study anti-tumor specific immune response to treatment.
- Anti-Tumor Response [ Time Frame: 30 days after the last dose ] [ Designated as safety issue: No ]To study radiological and pathological changes.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
AlloVax(TM) - the intradermal injection of AlloSim(TM) followed immediately by the intradermal injection of CRCL weekly for 3 weeks followed by intravenous infusion of AlloStim(TM) in week 4 (cycle 1 = 4 weeks. Total 4 cycles).
Personalized anti-cancer vaccine Intradermal injection AlloSimt followed immediately by the intradermal injection of CRCL
Other Name: CRCL and AlloStimBiological: CRCL
autologous tumor-derived chaperone protein mixture
Other Names:Biological: AlloStim
AlloStim (ID) injection AlloStim (IV) infusion
Placebo Comparator: Placebo Arm
AlloVax(TM) placebo (the intradermal injection of AlloSim(TM) placebo followed immediately by the intradermal injection of CRCL placebo) weekly for 3 weeks followed by intravenous infusion of AlloStim(TM) placebo in week 4. (Cycle 1 = 4 weeks. Total 4 cycles).
This is a randomized, double blinded, placebo controlled study. The subjects and investigators will be blinded as to treatment arm. All accrued subjects will undergo tumor harvest procedures. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. Subjects are assigned 3:1 ratio to AlloVax(TM) (CRCL with AlloStim(TM)) or to placebo control arms. Both arms will receive best supportive care. Arm 1 will receive AlloVax(TM) (the intradermal injection of AlloSim(TM) followed immediately by the intradermal injection of CRCL) weekly for 3 weeks followed by intravenous infusion of AlloStim(TM) in week 4 (cycle 1). Arm 2 will receive AlloVax(TM) placebo weekly for 3 weeks followed by an intravenous infusion of AlloStim(TM) placebo in week 4 (cycle 1). This experimental treatment schedule will continue for 4 cycles.
|Contact: Zivile Katiliene, PhDfirstname.lastname@example.org|
|Contact: Thu Bui, MSemail@example.com|
|National Cancer Institute of Thailand||Recruiting|
|Contact: Somjin Chindavijak, MD +66-2-3547025 firstname.lastname@example.org|
|Principal Investigator: Somjin Chindavijak, MD|
|Sub-Investigator: Wirote Lausoontornsiri, MD|
|Sub-Investigator: Ekapob Sangariyavanich, MD|
|Sub-Investigator: Wilaporn Pagdeedindan, MD|
|Study Director:||Zivile Katiliene, PhD||Immunovative Clinical Research, Inc|