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| Therapy Name | Irinotecan + Naxitamab + Sargramostim + Temozolomide |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Irinotecan | Camptosar | CPT-11 | TOPO1 inhibitor 11 | Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov). |
| Naxitamab | Danyelza | hu3F8 | GD2 Antibody 6 | Danyelza (naxitamab) is an antibody that targets the ganglioside GD2, potentially resulting in increased anti-tumor immune response against GD2-expressing tumor cells (PMID: 22754766). Danyelza (naxitamab) is FDA approved for use in combination with GM-CSF in pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who achieved a partial response, minor response, or stable disease to prior therapy (FDA.gov). |
| Sargramostim | Leukine | GM-CSF|Prokine | ||
| Temozolomide | Temodar | Methazolastone|TMZ | Chemotherapy - Alkylating 18 | Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03189706 | Phase I | Irinotecan + Naxitamab + Sargramostim + Temozolomide | Study of Chemoimmunotherapy for High-Risk Neuroblastoma | Active, not recruiting | USA | 0 |
| NCT07027748 | Phase I | Irinotecan + Naxitamab + Sargramostim + Temozolomide | Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma | Recruiting | USA | 0 |
| NCT04560166 | Phase II | Irinotecan + Naxitamab + Sargramostim + Temozolomide | Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma | Terminated | 2 |