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

NCT00861107 | Completed Phase 1

• 1 other identifier: ITL-002-CRYO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Cancer

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

Outcome Measures

Primary Outcomes (1)

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

  90 days

Secondary Outcomes (2)

• evaluation of the anti-tumor effect of AlloStim administration

  90 days

• evaluation of the immunological response to AlloStim administration

  90 days

Interventions

AlloStim-7 BIOLOGICAL

intradermal injection once a week for 3 weeks

Also known as: Priming Phase

percutaneous tumor cryoablation PROCEDURE

ablation of a tumor by percutaneous cryoablation under CT guidance

AlloStim8 or AlloStim-9 BIOLOGICAL

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.

Also known as: Immune activation phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (1)

Immunovative Clinical Research, Inc

Carlsbad, California, 92010, United States

Location

Related Publications (1)

• 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.

  PMID: 18834631 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis; Colorectal Neoplasms; Breast Neoplasms; Melanoma; Gastrointestinal Neoplasms; Prostatic Neoplasms; Kidney Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Michael Har-Noy

  Mirror Biologics, Inc.

  STUDY DIRECTOR

• Michael Berger, MD

  Immunotherapy Clinical Associates, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)