Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck
Condition: Cancer of Head and Neck; Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): AlloVax; CRCL; AlloStim
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Personalized anti-cancer vaccine with AlloStim(TM) and CRCL; autologous tumor-derived chaperone protein mixture; AlloStim (ID) injection AlloStim (IV) infusion
Other intervention name(s): CRCL and AlloStim; Chaperone Rich Cell Lysate; CRCL injection; AlloStim ID; AlloStim IV
Intervention model: Single Group Assignment
Intervention model description: 12 subjects with externally measurable disease
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and neck cancers; tumor vaccine; immunotherapy; personalized anti-cancer vaccine