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Phase I/II Study of a Therapeutic Cancer Vacccine Created In-situ in Patients With Refractory or Metastatic Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Cancer

Thank you

Trial Information

Phase I/II Study of a Therapeutic Cancer Vacccine Created In-situ in Patients With Refractory or Metastatic Cancer

This is a Phase I/II clinical study to investigate the feasibility of creating a
personalized anti-tumor vaccine within the body of patients with advanced cancers. The aim
of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine
protocol that has three separate phases. Cancer patients generally present with an immune
response to cancer biased to a Th2 response, while a Th1 response is considered necessary
for mediating anti-tumor immunity. The first step of the study consists of three (3) weekly
intradermal priming doses of AlloStim. The aim of this step is to create Th1 immunity to
the alloantigens in AlloStim, thus increasing the number of Th1 cells in circulation. The
second step of the protocol involves the cryoablation of a selected tumor lesion followed by
an intratumoral AlloStimTM injection. The aim of this step is to generate tumor-specific CTL
killer cells in the circulation. The final step is an intravenous infusion of AlloStim. The
aim of this step is to activate circulating Th1 cells, killer cells, and natural killer
cells The further aim of this step is to create an inflammatory environment that can
break-down the ability of the tumor to avoid an anti-tumor immune response.

Inclusion Criteria:

- 18 years or older

- Metastatic cancer refractory to at least one course of active chemotherapy or prior
radiation therapy, including metastatic breast cancer, colorectal cancer, non-small
cell lung cancer, ovarian or other gynecological cancer, prostate cancer, pancreatic
or other GI cancer, melanoma, head or neck cancer or lymphoma/plasmacytoma.

- Measurable disease determined upon review of abdominal and/or chest CT scan within 60
days of evaluation for study inclusion with a target tumor lesion for cryoablation
located in liver, kidney, bone, pancreas, lymph node, skin, neck or prostate deemed
to be accessible for percutaneous access.

- Acceptable cryoablation procedure technique risk: the target tumor for ablation must
have adequate distance from adjacent vasculature and other organs to permit safe
application of cryoprobe (generally, more than a 2.5cm clearance of the cryoprobe
from any vital structure such as the bowel, inferior vena cava, or aorta). The safety
assessment of the cryoprobe placement will be made an attending radiologist based on
imaging studies.

- Life expectancy >180 days

- No bevacizumab (Avastin®) within 6 weeks of planned cryoablation procedure

- ECOG status 0-1

- No concurrent medication known to interfere with platelet function or coagulation
(e.g., aspirin, ibuprofen, clopidogrel, or warfarin) unless such medications can be
discontinued for an appropriate time period based on the drug half-life and known
activity (e.g., aspirin for 7 days) prior to cryoablation procedure

- No low molecular weight heparin preparations unless can be discontinued 8 hours prior
to cryoablation

- At least 2 weeks since prior cytotoxic chemotherapy

- Absolute granulocyte count ≥ 1,200/mm3

- Platelet count ≥ 100,000/mm3

- PT/INR ≤ 1.5

- INR correctable to ≤ 1.5 or a PT/PTT correctable to normal limits. Patients
receiving anti-coagulation treatment with an agent such as warfarin or heparin
may be allowed to participate. For patients on warfarin, the INR should be
monitored weekly prior to the cryoablation day 21 to assure INR is stable.
However, heparin or warfarin must be withheld prior to cryoablation such that
the above criteria are met.

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 1.5 mg/dL

- Total bilirubin ≤ 1.5 times normal

- Alkaline phosphatase ≤ 2.5 times normal (≤ 5 times normal if liver involvement)

- Aspartate aminotransferase (AST) or (SGOT) ≤ 2.5 times ULN

- Alanine aminotransferase (ALT) or (SGPT) ≤ 2.5 times ULN

- Not pregnant or lactating

- Patients with child bearing potential must agree to use adequate contraception

- No psychiatric or addictive disorders or other condition that, in the opinion of the
investigator, would preclude study participation

- Study specific informed consent

Exclusion Criteria:

- Taking anticoagulant medication for concomitant medical condition (unless can be
safely discontinued for cryoablation procedure)

- Prior allogeneic bone marrow/stem cell or solid organ transplant

- Chronic use (> 2 weeks) of greater than physiologic doses of a corticosteroid agent
(dose equivalent to > 10 mg/day of prednisone) within 30 days of the first day of
study drug treatment

- Topical and inhaled corticosteroids are permitted

- Concomitant autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis,
autoimmune thyroid disease, uveitis)

- Prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock

- Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or
tacrolimus within 3 months of study entry

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

evaluation of any drug-related toxicity associated with AlloStim administration as well as the reversibility of such toxicity.

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Dr. Michael Har-Noy

Investigator Role:

Study Director

Investigator Affiliation:

Immunovative Therapies, Ltd.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

May 2011

Related Keywords:

  • Metastatic Cancer
  • Colorectal cancer
  • Breast Cancer
  • Melanoma
  • GI cancer
  • Prostate cancer
  • Kidney cancer
  • Lung cancer
  • all types metastatic cancer where at least one tumor lesion is accessable for percutaneous cryoablation
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Immunovative Clinical Research, Inc Carlsbad, California  92010