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Solid Tumors Stage II, Stage III and Stage IVPhase 1/2NCT01065441

Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer

A Phase 1/2 study testing AlloStim and Cryoablation in people with Solid Tumors Stage II, Stage III and Stage IV and Breast Cancer, run by Michael Har-Noy at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AlloStim and Cryoablation
How many people
9 participants
Where
1 siteIsrael
Study dates
Dec 2010to Jul 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 vaccine)
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  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah-Hebrew University Medical Center

    Jerusalem, 91120

Other trials in Israel

About this study

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

A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory cytokines.

Read the detailed description

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.

Being tested
AlloStim, Cryoablation
Keywords
breast cancer, colorectal cancer, prostate cancer, melanoma, ovarian cancer, GI cancer, Sarcoma, Renal Cell Carcinoma
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Melanoma, Ovarian Neoplasms, Sarcoma, Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlloStimBiological

    Patients meeting eligibility criteria will be primed with at least three and up to nine intradermal AlloStim-TM injections at a frequency of every 2-8 days at doses between 1-4 x 10^7 cells

  • CryoablationProcedure or surgery

    Percutaneous cryoablation of selected tumor lesion under CT or US guidance

  • AlloStimBiological

    intratumoral injection of AlloStim-TM into cryoablated tumor lesion at a dose of 1-6 x 10^7 cells

  • AlloStimBiological

    intravenous AlloStim-TM at doses between 1 x 10^7 to 1 x 10^9 cells

  • AlloStimBiological

    Intraperitoneal AlloStim-TM infusion in patients with peritoneal carcinomatosis and/or ascites

  • AlloStimBiological

    Patients with malignant pleural effusion may receive intrapleural AlloStim-TM infusion at a dose of 5-10 x 10^7 cells.

  • AlloStimBiological

    Patients with palpable tumors may receive alcohol ablation and intratumoral AlloStim-TM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 90 days

Secondary outcomes (2)

  1. The secondary end-point is the evaluation of the anti-tumor effect of AlloStimTM administration.

    Measured: 1 year

  2. The tertiary end-point is the evaluation of the immunological response to AlloStim-TM administration.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01065441
Sponsor's protocol ID
ITL-002-HMC
Status last verified
Jan 2020
First submitted
7 Feb 2010
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.

    PubMed 18834631

  • Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.

    PubMed 18565579

  • Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.

    PubMed 18054441

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AlloStim and Cryoablation in people with Solid Tumors Stage II, Stage III and Stage IV and Breast Cancer, run by Michael Har-Noy at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01065441, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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