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Intradermal injection (ID) of AlloStim(TM) (1ml) on day 4 and 7. AlloVax Treatment: ID injection of AlloSim(TM) (1 ml) followed immediately by the ID injection of CRCL (1ml) on day 11 and 14 in same location on the left arm and on day 18 and 21 in the same location on the right arm. Intravenous infusion of AlloStim(TM)(5ml) and a CRCL alone Intradermal injection on Day 27.

AlloVax

CRCL

AlloStim

Yaron Ilan, MD

The purpose of this study is to determine the safety and the immunological, radiological, and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC treatments or have failed all approved HCC treatments. 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 these two components provides a vaccine designed to bring out an immune response capable of finding and killing the tumor cells.

All accrued subjects will undergo tumor harvest procedure. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. This study consists of three phases: priming phase, vaccination phase, and activation phase. The priming phase involves intradermal injections of AlloStim(TM). The aim of this phase is to increase the titer of Th1 immune cells in circulation. The vaccination phase involves the intradermal injections of AlloSim(TM) immediately followed by the intradermal injections of CRCL. This phase is designed to elicit tumor-specific immunity. The activation phase involves intravenous infusion of AlloStim(TM). This phase is designed to activate memory cells and NK cells and cause them to extravasate and traffic to tumor sites.

An Individualized Anti-Cancer Vaccine Study in Patients With HCC

An Individualized Anti-Cancer Vaccine (AlloVaxTM) Study in Patients With Refractory Hepatocellular Carcinoma (HCC)

To determine if there are any evidence of anti-tumor immune-mediated response by radiological and pathological changes.

To assess adverse events and laboratory abnormalities associated with AlloVax

Determine if AlloVax elicits detectable tumor specific immunity

Biomarker concentration will be evaluated at different time points.

Immunovative Therapies, Ltd.

Symptoms and General Pathology

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Head and Neck Neoplasms

Disease Attributes

AlloStim priming followed by AlloStim+CRCL priming and AlloStim IV. 3 cycles

Personalized anti-cancer vaccine with AlloStim(TM) and CRCL

autologous tumor-derived chaperone protein mixture

AlloStim (ID) injection AlloStim (IV) infusion

Michael Har-Noy, Dr.

The purpose of this study is to determine the safety and tumor debulking efficacy 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 cross-reactivity of alloantigen specific recognition with tumor-specific recognition. All the key components necessary to develop tumor-specific immunity by 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.

This is a Phase II study following up on a previous Phase I/II study in chemotherapy refractory metastatic disease with \<90 day survival expectancy. In the Phase I/II study all patients progressed using RECIST criteria. However, 11/42 (26%) were alive at 1yr and 9/42 (21%) alive at 2 yr. Therefore, CT scans did not correlate with clinical presentation and "pseudo-progression" was suspected. This study was designed to select subjects with visible tumor burden on the head, neck or tongue that could be measured and photographed so as not to rely solely on CT scans to determine anti-tumor debulking efficacy. Subjects are initially primed with intradermal AlloStim(TM) injections creating systemic anti-allo-specific cellular immunity. Tumor biopsy samples taken prior to dosing were processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine containing enriched heat shock proteins which are believed to chaperone tumor-specific neoantigens . AlloStim(TM) was then injected with CRCL into primed subjects to create tumor-specific cellular immunity. Subsequently, subjects are infused with intravenous AlloStim(TM) to cause extravasation of memory cells to the tumor lesions. The protocol including intradermal AlloStim(TM) day 0, 3, 7, 10. Intradermal AlloStim(TM)+CRCL on days 14, 17, 21, 24. Intravenous AlloStim(TM) day 28. This experimental treatment schedule will continue for 3 cycles.

12 subjects with externally measurable disease

Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck

Phase II Study Designed To Evaluate Safety and Tumor Debulking Mechanism of an Individualized Cancer Vaccine (AllovaxTM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck.

Tumor response evaluation by clinical exam including photographs of visible tumor lesions on head, neck and/or tongue (endoscopic) and by CT scan assessment for change in target lesion tumor volume (TV). TV is defined as the volume occupied by macroscopic visible target lesion in two longest cross-sectional diameters.

change in tumor pathology and immune cell inflitration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Individualized Anti-Cancer Vaccine Study in Patients With HCC	NCT01995227	Hepatocellular ...	AlloVax CRCL AlloStim	18 Years -	Immunovative Therapies, Ltd.
Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck	NCT01998542	Cancer of Head ... Squamous Cell C...	AlloVax CRCL AlloStim	18 Years - 70 Years	Immunovative Therapies, Ltd.
Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck	NCT01998542	Cancer of Head ... Squamous Cell C...	AlloVax CRCL AlloStim	18 Years - 70 Years	Immunovative Therapies, Ltd.

Spots Global Cancer Trial Database for crcl

Every month we try and update this database with for crcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for crcl

Every month we try and update this database with for crcl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.