Clinical trial · Interventional
Intratumoral Injection Of Alpha-Gal Glycosphingolipids
Phase I Study To Evaluate The Toxicity And Feasibility Of Intratumoral Injection Of Alpha-Gal (Beta-galactosidase ) Glycosphingolipids In Patients With Advanced Melanoma
NCT00668512CI-TRIAL-00017178completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antimelanoma injection of GSL alpha-Gal | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antimelanoma injection-GSL alpha-Gal
- description
- Intervention consists of 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
- interventionNames
- Biological: Antimelanoma injection of GSL alpha-Gal
Primary outcomes (1)
- measure
- Grade 3/4 toxicity
- timeFrame
- 11-12 weeks
- description
- Grade 3/4 toxicity or adverse event during injection protocol or up to a month after
Secondary outcomes (1)
- measure
- Clinical response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with recurrent melanoma who have failed standard therapies, or are not candidates for standard therapies. 2. Patients must have at least one measurable cutaneous lesion that is accessible and suitable for injection of the GSL alpha-GAL. 3. 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. 4. Patients should be judged by the investigator to be able to undergo safely the procedure needed to inject the tumor with GSL alpha-GAL. 5. Age \>18 years old. 6. 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) 7. 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. 8. Patients must be negative for HIV (circulating antibody), Hepatitis B (circulatory antigen), and Hepatitis C (circulating antibody). 9. 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: 1. Patients who are pregnant or nursing (PRN serum pregnancy test to be done at week -1). 2. Patients under the age of 18. 3. Patients with severe infections or septicemia. 4. Patients with a history of autoimmune disease. 5. Patients in, or about to be in, active treatment with chemotherapy or steroids. 6. Patients who refuse HIV/hepatitis testing and patients who do not sign an approved consent form 7. 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. 8. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
References
Publications (3)
- BACKGROUNDMalmberg 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
- BACKGROUNDSpiotto MT, Fu YX, Schreiber H. Tumor immunity meets autoimmunity: antigen levels and dendritic cell maturation. Curr Opin Immunol. 2003 Dec;15(6):725-30. doi: 10.1016/j.coi.2003.09.018. PMID 14630209
- RESULTLugade 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