Status:
COMPLETED
Intratumoral Injection Of Alpha-Gal Glycosphingolipids
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 th...
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 sep...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00668512
Start Date
March 1 2007
End Date
March 1 2014
Last Update
March 19 2015
Active Locations (1)
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1
Universiity of Wisconsin
Madison, Wisconsin, United States, 53792