Clinical trial · Interventional
Suicide Plus Immune Gene Therapy for Advanced Melanoma
Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma
NCT03338777CI-TRIAL-00043644IGTM-101terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to achieve primary objective
Summary
Brief summary (as posted)
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Suicide plus immunogene therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Suicide plus immunogene therapy
- description
- Intra and peritumoral infiltrates with multiple injections of lipoplexes carrying the HSVtk suicide gene co-administered with GCV and subcutaneous vaccine produced with formolized allogeneic tumor extracts and lipoplexes carrying hIL-2 and hGM-CSF genes.
- interventionNames
- Biological: Suicide plus immunogene therapy
Primary outcomes (1)
- measure
- Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03
- timeFrame
- 1 year
- description
- Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE\_4.03\_2010-06-14\_QuickReference\_5x7.pdf).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically and / or cytologically confirmed melanoma. * Patients progressed or are intolerant to conventional systemic treatments. * Patients that are not candidates for surgery under oncologic criteria (complete resection). * Performance status (ECOG) 0 or 1. * Patients with life expectancy greater than 6 months. * Patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis). * Patients with measurable disease (according to RECIST 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation) * Patients with signed informed consent. Exclusion Criteria: * Patients with uncontrolled cardiovascular disease * Patients with uncontrolled respiratory disease. * Patients with uncontrolled immune disease. * Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment. * Patients performing other experimental therapies. * Patients who are pregnant or breastfeeding. * Patients undergoing concurrent chemotherapy or radiation therapy. * Uncontrolled diabetes. * Patients with active diagnosis of other malignant neoplasms. * HIV-positive patients. * Uncontrolled thyroid abnormality. * Patients with significant medical morbidity. * Patients with a history of allergic reactions to chemicals or similar to those used in this study. * Metastasis in the central nervous system. * Laboratory eligibility criteria excluded: * Hemoglobin: \<8 g / dL, leukocytes: \<3,000 / mm3, platelets: \<100,000 / mm3, neutrophils: \<1000 / mm3, hematocrit: \<25%. bilirubin\> 2.0 mg / dL, GOT or GPT: 2.5 times\> than normal upper institutional limit (ULN), alkaline phosphatase: 2 times\> ULN, creatinine\> 2.0 mg / dL, creatinine clearence : \<60 ml / min / 1.73 m2.
References
Publications (0)
Data not yet available
No reference posted for this study.