NCT01998542

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	AlloVax	Personalized anti-cancer vaccine with AlloStim(TM) and CRCL
BIOLOGICAL	CRCL	autologous tumor-derived chaperone protein mixture
BIOLOGICAL	AlloStim	AlloStim (ID) injection AlloStim (IV) infusion

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-06-01
• Completion: 2017-11-01
• First posted: 2013-11-29
• Last updated: 2020-01-23

Locations

1 site across 1 country: Thailand