Zivile Katiliene, PhD, Immunovative Clinical Research, Inc
Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck
Cancer of Head and Neck
Squamous Cell Carcinoma of the Head and Neck
Phase 1/Phase 2
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.
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
1. Adult males and female patients aged 18 to 70 years old, inclusive, at screening
2. 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.
3. Patients must have a tumor safely accessable for surgical excision resulting in a
minimum of 0.5 g of tumor sample for CRCL processing.
4. Patients must have measurable disease according to revised RECIST v.1.1 guidelines
with at least one lesion deemed to be safely accessible for serial biopsy.
5. ECOG ≤2.
6. The result of screening test were in the criteria:
6.1 Adequate organ function including:
- WBC >3000/mm3
- Platelets >100,000/mm3.
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
- Serum Total bilirubin < 2 x ULN mg/dL,
- ALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
- Serum creatinine (SCR) <2.0 x ULN, or
- Creatinine clearance (CCR) >30 mL/min.
6.2 All patients have a pre-study echocardiogram without significant abnormalities
or Ejection fraction >50%.
6.3 All patients must be screened to be negative for HIV1, HIV2, HTLVI, HTLVII, HBV,
HCV and RPR (syphilis).
6.4 Women of child-bearing potential must have a negative urine or serum pregnancy
test result within 72 hours prior to the start of study drug administration.
7. All patients of child producing potential must agree to use contraception or
avoidance of pregnancy measures while enrolled on study and receiving the
8. 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
1. Clinical evidence or radiological evidence of nasopharyngeal primaries.
2. Clinical evidence or radiological evidence of brain metastasis.
3. History of severe hypersensitivity to monoclonal antibody drugs or any
contraindication to any of the study drugs.
4. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple
sclerosis, autoimmune thyroid disease, uveitis).
5. Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy,
heat shock vaccine).
6. Clinical requirement for systemic steroids or current immunosuppressive therapy,
including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of
7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, requiring parenteral antibiotics, symptomatic congestive heart failure,
severe myocardial insufficiency, cardiac arrhythmia
8. All infections must be resolved and the patient must remain a febrile for seven days
prior to being placed in the study.
9. History of blood transfusion reactions.
10. Psychiatric or addictive disorders or other condition that, in the opinion of the
investigator, would preclude study participation.
11. Pregnant or breast feeding.
The patient will discontinuation from the participation in the study:
1. Less than 12 doses of CRCL able to be produced
2. Tumor sample for CRCL processing contains less than 80% tumor.
Zivile Katiliene, PhD
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Information obtained from ClinicalTrials.gov, on
3/11/2014. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: