Intratumoral Injection Of Alpha-Gal Glycosphingolipids
This study is currently recruiting participants.
Verified October 2012 by University of Massachusetts, Worcester
Sponsor:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Giles Whalen, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00668512
First received: April 25, 2008
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
This is a Phase I pilot study to evaluate the toxicity of two intra-tumoral injections of GSL alpha-GAL in patients with advanced or metastatic cutaneous melanoma. Patients who have failed standard therapies or are not eligible for standard treatment will be eligible for this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Melanoma |
Biological: Intramelanoma injection of GSL alpha-Gal |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Phase I Study To Evaluate The Toxicity And Feasibility Of Intratumoral Injection Of Alpha-Gal Glycosphingolipids In Patients With Advanced Melanoma |
Resource links provided by NLM:
Further study details as provided by University of Massachusetts, Worcester:
Primary Outcome Measures:
- Grade 3/4 toxicity [ Time Frame: 11-12 weeks ] [ Designated as safety issue: Yes ]Grade 3/4 toxicity or adverse event during injection protocol or up to amonth after
Secondary Outcome Measures:
- Clinical response [ Time Frame: 2 years ] [ Designated as safety issue: No ]Injected tumor deposit regression (RECIST), regression of other known metastases (RECIST), progresson of disease (new metastes)
Other Outcome Measures:
- Immune response in injected lesion [ Time Frame: six weeks ] [ Designated as safety issue: No ]Evidence of immune cell infiltration of injected tumor: histologic comparison of biopsy of injected lesion with pre injection biopsy of same lesion
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intramelanoma injection of GSL alpha-Gal
Injection of a single melanoma metastasis with two injections of GSL alpha-Gal separated by four weeks. Both injections done with the same dose of GSL alpha-GAL each time. Phase 1 dose escalating scheme: 0.1mg, 1 mg, 10mg
|
Biological: Intramelanoma injection of GSL alpha-Gal
Single arm, phase 1 trial of escalating doses of GSL alpha-Gal (0.1mg, 1mg, 10mg)injected into a melanoma metastasis at day 0 and then again 4 weeks later.
Other Name: Alph-Gal Glycosphingolipids
|
Detailed Description:
A standard Phase I dose escalation model will be used to define the maximum tolerated dose (MTD) of GSL alpha-GAL that can be administered directly into the tumor lesion on two separate injections separated by 4-weeks. This trial will serve as the basis for future Phase II trials utilizing multiple injections of GSL alpha-GAL in refractory solid tumors.
Additionally, in this study we will look for histologic evidence of an immune response against the injected melanoma lesions which matches that seen in mice. Our hypothesis for this study is that a second injection of GSL alpha-GAL into a melanoma lesion will not precipitate an allergic or autoimmune reaction, but will cause a histologically evident immune response to the tumor.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with recurrent melanoma who have failed standard therapies, or are not candidates for standard therapies.
- Patients must have at least one measurable cutaneous 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 has 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 >18 years old.
- ECOG performance of <2. INR<1.5 and a PTT no greater than normal limits within 1 week prior to intra-tumoral injection (For patients who may be on blood thinners)
- Laboratory Criteria (completed <2 weeks before enrollment) Hematologic: WBC > 3500/mm3 or ANC > 1500/mm3 and platelet count > 100 000/ mm3 Hepatic: Total bilirubin < 4.0 mg/dl Renal: Creatinine < 2.2 mg/dl.
- Patients must be negative for HIV (circulating antibody), Hepatitis B (circulatory antigen), and Hepatitis C (circulating antibody).
- Patients should have an expected survival of >6 weeks and should not have other systemic anti-tumor treatments planned during this time frame.
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not eligible:
- Patients who are pregnant or nursing (PRN serum pregnancy test to be done at week -1).
- 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 experiment drug study during this study treatment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668512
Contacts
| Contact: Giles Whalen, MD | (508) 334-5202 | Giles.Whalen@umassmemorial.org |
| Contact: Uri Galili, PhD | 508-856-4188 | Uri.Galili@umassmed.edu |
Locations
| United States, Wisconsin | |
| Universiity of Wisconsin | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Mark Albertini, MD mralbert@wisc.edu | |
| Contact: Jennifer Collins (608) 263-2599 jcollins@medicine.wisc.edu | |
| Principal Investigator: Mark Albertini, MD | |
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
| Principal Investigator: | Giles Whalen, MD | University of Massachusetts, Worcester |
More Information
Publications:
| Responsible Party: | Giles Whalen, Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT00668512 History of Changes |
| Other Study ID Numbers: | UM200701 |
| Study First Received: | April 25, 2008 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Massachusetts, Worcester:
|
metastatic cutaneous melanoma alpha-gal glycolipids |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 19, 2013