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A Phase I/II Study of an Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancers

Phase 1/Phase 2
18 Years
Not Enrolling
Solid Tumors Stage II, Stage III and Stage IV, Breast Cancer, Colorectal Cancer, Prostate Cancer, Melanoma, Ovarian Cancer, Sarcoma, Non-small Cell Lung Cancer

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Trial Information

A Phase I/II Study of an Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancers

This is a Phase I/II clinical study to investigate the optimal protocol and indication for
creating a personalized anti-tumor vaccine within the body of patients with cancer. The aim
of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine
protocol that has three separate steps. 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 multiple
intradermal priming doses of AlloStimTM. The aim of this step is to create Th1 immunity to
the alloantigens in AlloStimTM, 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 AlloStimTM.
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. In patients with
partial responses and recurrence of disease, additional intravenous "booster" infusions are
utilized to reactivate the circulating immune cells.

Inclusion Criteria:

- 18 years or older

- Stage II-IV including 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 or
alcohol ablation located in liver, kidney, bone, lung, adrenal, pancreas, lymph node,
skin, neck or prostate deemed to be accessible for percutaneous access or
carcinomatosis or malignant ascites or malignant pleural effusion.

- When applicable, 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 >90 days

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

- ECOG status 0-2

- 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

o 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 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

o Topical and inhaled corticosteroids are permitted

- Concomitant active 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

- History of blood transfusion reactions

- Known allergy to bovine products

- Know allergy to murine products

- Progressive viral or bacterial infection

o All infections must be resolved and the patient must remain afebrile for seven days
without antibiotics prior to being placed on study

- Cardiac disease of symptomatic nature or cardiac ejection fraction < 45%

- Symptomatic pulmonary disease or FEV1, FVC, and DLCO ≤ 50% predicted

- History of HIV positivity or AIDS o HBV and/or HCV positivity is permitted

Type of Study:


Study Design:

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

Outcome Measure:

The primary endpoint is the evaluation of any drug-related toxicity associated with AlloStimTM administration as well as the reversibility of such toxicity.

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Tamar Peretz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization


Israel: Ministry of Health

Study ID:




Start Date:

December 2009

Completion Date:

July 2012

Related Keywords:

  • Solid Tumors Stage II, Stage III and Stage IV
  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Melanoma
  • Ovarian Cancer
  • Sarcoma
  • Non-Small Cell Lung Cancer
  • breast cancer
  • colorectal cancer
  • prostate cancer
  • melanoma
  • ovarian cancer
  • GI cancer
  • Sarcoma
  • Renal Cell Carcinoma
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Sarcoma