Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection

NCT00668382 | Completed Phase 1 Results DMC

• 1 other identifier: UM200702
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced, refractory solid tumors who have failed standard therapies or are not eligible for standard treatment.

Conditions

Neoplasm Metastases

Keywords

Cancerous solid tumors; Alpha-Gal Glycosphingolipids

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Greater Than Grade 3 or 4 Toxicity

  Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection

  1 month

Study Arms (1)

Alpha-Gal Glycosphingolipid injection

EXPERIMENTAL

Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)

Biological: Alpha-Gal Glycosphingolipid

Interventions

Alpha-Gal Glycosphingolipid BIOLOGICAL

Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity

Alpha-Gal Glycosphingolipid injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with solid tumors who have failed standard therapies, or are not candidates for standard therapies.
• Patients must have at least one measurable lesion that is accessible and suitable for injection of the GSL alpha-GAL.
• Patients should not be undergoing any active treatment with chemotherapy, radiotherapy, or steroids (either because the patient or the treating physician have decided not to employ these therapies at this time, or because they had already been tried and failed). If they have been treated with these modalities, the treatments should have been completed at least two weeks prior to date of injection of GSL alpha-GAL.
• Patients should be judged by the investigator to be able to undergo safely the procedure needed to inject the tumor with GSL alpha-GAL.
• Age equal or over 18 years old.
• ECOG (Eastern Cooperative Oncology Group ) performance of less than 2. (International Normalized Ratio) INR less than 1.5 and a (Partial Thromboplastin Time) PTT no greater than normal limits within 1 week prior to intra-tumoral injection (For patients who requires invasive procedure for intra-tumoral injection).
• Laboratory Criteria (completed equal or less 2 weeks before enrollment) Hematologic: (White Blood Cell Count) WBC equal or above 3500/millimeter-cubed or (Absolute Neutrophil Count) ANC equal or above 1500/millimeter-cubed and platelet count equal or above 100,000/ millimeter-cubed.
• Hepatic: Total bilirubin equal or less 4.0 milligrams/deciliter. Renal: Creatinine equal or less 2.2 milligrams/deciliter.
• Patients must be negative for HIV (circulating antibody), Hepatitis B (circulating antigen), and Hepatitis C (circulating antibody).
• Patients should have an expected survival of more than 6 weeks and should not have other systemic anti-tumor treatments planned during this time frame.

You may not qualify if:

• Patients who are pregnant (as determined by a positive serum HCG (Human Chorionic Gonadotropin) in patients of childbearing potential) or nursing.
• Patients under the age of 18.
• Patients with severe infections or septicemia.
• Patients with a history of autoimmune disease.
• Patients in, or about to be in, active treatment with chemotherapy or steroids.
• Patients who refuse HIV/hepatitis testing and patients who do not sign an approved consent form.
• Patient has received other investigational drugs within 14 days before enrollment or is expected to participate in an experimental drug study during this study treatment.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655-0108, United States

Location

Related Publications (4)

• Lugade AA, Moran JP, Gerber SA, Rose RC, Frelinger JG, Lord EM. Local radiation therapy of B16 melanoma tumors increases the generation of tumor antigen-specific effector cells that traffic to the tumor. J Immunol. 2005 Jun 15;174(12):7516-23. doi: 10.4049/jimmunol.174.12.7516.

  PMID: 15944250 RESULT

• Malmberg KJ. Effective immunotherapy against cancer: a question of overcoming immune suppression and immune escape? Cancer Immunol Immunother. 2004 Oct;53(10):879-92. doi: 10.1007/s00262-004-0577-x. Epub 2004 Jul 28.

  PMID: 15338206 RESULT

• DiGiacomo A, North RJ. T cell suppressors of antitumor immunity. The production of Ly-1-,2+ suppressors of delayed sensitivity precedes the production of suppressors of protective immunity. J Exp Med. 1986 Oct 1;164(4):1179-92. doi: 10.1084/jem.164.4.1179.

  PMID: 2944983 RESULT

• Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.

  PMID: 10553041 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No allergic/immune toxicity. The single toxicity/AE was bacterial infection with UGI flora at injection site following EUS (endoscopic ultra-sound) guided injection of pancreatic cancer. Added injections covered with antibiotic prophylaxis.

Results Point of Contact

• Title: Dr. Sheila Noone
• Organization: UMass Medical Scool

Sheil.Noone@umasmed.edu

508 856 5015

Study Officials

• Giles Whalen, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principle Investigator

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: July 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 15, 2013
• Results First Posted: November 26, 2012

Record last verified: 2013-05

Locations

US (1)