Clinical trial · Interventional
Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection
Phase I Study To Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection Of Alpha-Gal Glycosphingolipids In Patients With Advanced Or Refractory Solid Tumors
NCT00668382CI-TRIAL-00010295completedPhase 1Results postedClinicalTrials.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 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
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 |
|---|---|---|---|
| Neoplasm Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha-Gal Glycosphingolipid | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alpha-Gal Glycosphingolipid injection
- description
- Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
- interventionNames
- Biological: Alpha-Gal Glycosphingolipid
Primary outcomes (1)
- measure
- Number of Subjects With Greater Than Grade 3 or 4 Toxicity
- timeFrame
- 1 month
- description
- Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with solid tumors who have failed standard therapies, or are not candidates for standard therapies. 2. Patients must have at least one measurable 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 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. 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 equal or over 18 years old. 6. 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). 7. 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. 8. Patients must be negative for HIV (circulating antibody), Hepatitis B (circulating antigen), and Hepatitis C (circulating antibody). 9. 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. Exclusion Criteria: 1. Patients who are pregnant (as determined by a positive serum HCG (Human Chorionic Gonadotropin) in patients of childbearing potential) or nursing. 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 experimental drug study during this study treatment. 8. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
References
Publications (4)
- 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
- RESULTMalmberg 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
- RESULTDiGiacomo 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
- RESULTShimizu 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