Recruitment

Recruitment Status
Completed
Estimated Enrollment
52

Inclusion Criteria

Patients must have visible external tumors measurable with at least one lesion deemed to be safely accessible for serial biopsy.
Serum creatinine (SCR) <2.0 x ULN, or
ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
...
Patients must have visible external tumors measurable with at least one lesion deemed to be safely accessible for serial biopsy.
Serum creatinine (SCR) <2.0 x ULN, or
ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
All patients of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product.
ECOG ≤2.
Adult males and female patients aged 18 to 70 years old, inclusive, at screening visit.
Platelets >100,000/mm3.
Patients must have a tumor safely accessable for biopsy resulting in a minimum of 0.1 g of tumor sample for CRCL processing.
Patients with histopatholologically or cytologically confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery, chemotherapy or radiation. No nasopharyngeal primaries.
Serum Total bilirubin < 2 x ULN mg/dL,
Absolute neutrophil count ≥ 1,500/mm³
WBC >3000/mm3
Creatinine clearance (CCR) >30 mL/min.
Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate.

Exclusion Criteria

Clinical evidence or radiological evidence of brain metastasis.
Clinical requirement for systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry.
Pregnant or breast feeding.
...
Clinical evidence or radiological evidence of brain metastasis.
Clinical requirement for systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry.
Pregnant or breast feeding.
Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs.
Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia
History of blood transfusion reactions.
All infections must be resolved and the patient must remain a febrile for seven days prior to being placed in the study.
Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
Clinical evidence or radiological evidence of nasopharyngeal primaries.

Summary

Conditions
  • Cancer of Head and Neck
  • Squamous Cell Carcinoma of the Head and Neck
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: 12 subjects with externally measurable diseaseMasking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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, ...

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.

Inclusion Criteria

Patients must have visible external tumors measurable with at least one lesion deemed to be safely accessible for serial biopsy.
Serum creatinine (SCR) <2.0 x ULN, or
ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
...
Patients must have visible external tumors measurable with at least one lesion deemed to be safely accessible for serial biopsy.
Serum creatinine (SCR) <2.0 x ULN, or
ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
All patients of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product.
ECOG ≤2.
Adult males and female patients aged 18 to 70 years old, inclusive, at screening visit.
Platelets >100,000/mm3.
Patients must have a tumor safely accessable for biopsy resulting in a minimum of 0.1 g of tumor sample for CRCL processing.
Patients with histopatholologically or cytologically confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery, chemotherapy or radiation. No nasopharyngeal primaries.
Serum Total bilirubin < 2 x ULN mg/dL,
Absolute neutrophil count ≥ 1,500/mm³
WBC >3000/mm3
Creatinine clearance (CCR) >30 mL/min.
Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate.

Exclusion Criteria

Clinical evidence or radiological evidence of brain metastasis.
Clinical requirement for systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry.
Pregnant or breast feeding.
...
Clinical evidence or radiological evidence of brain metastasis.
Clinical requirement for systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry.
Pregnant or breast feeding.
Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs.
Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia
History of blood transfusion reactions.
All infections must be resolved and the patient must remain a febrile for seven days prior to being placed in the study.
Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
Clinical evidence or radiological evidence of nasopharyngeal primaries.

Tracking Information

NCT #
NCT01998542
Collaborators
Not Provided
Investigators
Study Director: Michael Har-Noy, Dr. Immunovative Therapies, Ltd.
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