Intratumoral Injection Of Alpha-Gal Glycosphingolipids

Completed · Phase 1

Conditions studied: Metastatic Melanoma

In brief

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.

Key facts

Study ID

NCT00668512

Run by

University of Massachusetts, Worcester

People needed

12

Starts

2007-03-01

Expected to finish

2014-03-01

Last updated by the study team

2015-03-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (Eastern Cooperative Oncology Group) performance of <2. International Normalized Ratio (INR)<1.5 and a PTT (partial thromboplastin time ) 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: (White Blood Cell Count) WBC > 3500/mm3 or (absolute neutrophil count) 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.

You may not qualify if…

• 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.

Where it is running

• Universiity of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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