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Metastatic CancerPhase 1/2NCT00861107

In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation

A Phase 1/2 study testing AlloStim-7, percutaneous tumor cryoablation and AlloStim8 or AlloStim-9 in people with Metastatic Cancer, run by Mirror Biologics, Inc. at 1 site in United States.

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

This is a Phase I/II study to investigate the feasibility of creating a personalized therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and an adjuvant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer
What is being tested?
AlloStim-7, percutaneous tumor cryoablation and AlloStim8 or AlloStim-9
How many people
50 participants
Where
1 siteUnited States
Study dates
Aug 2009to May 2011
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
  • 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
Show all 24Show fewer
  • 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

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Immunovative Clinical Research, Inc

    Carlsbad, California, 92010

Other trials in United States

About this study

Official title: 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 study to investigate the feasibility of creating a personalized therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and an adjuvant. In this study, tumor antigen is generated by freezing a tumor by a minimally invasive percutaneous (through the skin) cryoablation procedure. The study drug, AlloStim, is injected into the ablated tumor to promote development of an anti-tumor immune response.

Read the detailed description

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.

Being tested
AlloStim-7, percutaneous tumor cryoablation, AlloStim8 or AlloStim-9
Keywords
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
Medical subject headings
Neoplasm Metastasis, Colorectal Neoplasms, Breast Neoplasms, Melanoma, Gastrointestinal Neoplasms, Prostatic Neoplasms, Kidney Neoplasms, Lung Neoplasms

What participants receive

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

  • AlloStim-7Biological

    Also called Priming Phase

    intradermal injection once a week for 3 weeks

  • percutaneous tumor cryoablationProcedure or surgery

    ablation of a tumor by percutaneous cryoablation under CT guidance

  • AlloStim-7Biological

    Also called In-Situ Vaccine Phase

    intratumoral injection into cryoablated tumor lesion 1 hour after ablation

  • AlloStim8 or AlloStim-9Biological

    Also called Immune activation phase

    intravenous infusion of AlloStim one week following ablation procedure. First cohort to receive 10^8 cell dose and if no toxicity dose escalates to 10^9 cell dose.

What is being measured

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

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

    Measured: 90 days

Secondary outcomes (2)

  1. evaluation of the anti-tumor effect of AlloStim administration

    Measured: 90 days

  2. evaluation of the immunological response to AlloStim 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 posted13 Mar 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMar 2011
  4. Study completionMay 2011

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00861107
Sponsor's protocol ID
ITL-002-CRYO
Status last verified
Jun 2011
First submitted
12 Mar 2009
Last updated
8 Jun 2011
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AlloStim-7, percutaneous tumor cryoablation and AlloStim8 or AlloStim-9 in people with Metastatic Cancer, run by Mirror Biologics, Inc. at 1 site in United States.

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 7 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 8 Jun 2011. 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 United States. 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?

evaluation of any drug-related toxicity associated with AlloStim 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 NCT00861107, which also lists 1 linked publication.

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 8 Jun 2011.

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