Clinical trial · Interventional
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
A Phase 1 Dose Escalation Study of Seneca Valley Virus (NTX-010), A Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients With Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
- 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)
RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill even more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley virus-001 in treating young patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| Seneca Valley virus-001 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (NTX-010)
- interventionNames
- Biological: Seneca Valley virus-001
- Drug: cyclophosphamide
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Safety and tolerability
- timeFrame
- 12 months post-documented viral clearance
- measure
- Recommended phase II dose of Seneca Valley virus-001 (NTX-010)
- timeFrame
- 56 days
Secondary outcomes (3)
- measure
- Tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Neuroblastoma * Rhabdomyosarcoma * Wilms tumor * Retinoblastoma * Adrenocortical carcinoma * Carcinoid tumor * Relapsed or refractory disease * Measurable or evaluable disease * No known curative therapy or therapy proven to prolong survival with an acceptable quality of life * No known pulmonary tumors or metastases \> 5 cm, as evaluated by chest CT scan * No clinically significant pulmonary and/or pericardial effusions (≥ grade 3), as evaluated by ECHO * No primary CNS tumors or known metastatic CNS disease involvement PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) * Lansky PS 50-100% (for patients ≤ 16 years of age) * Peripheral ANC ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as no platelet transfusions within a 7-day period before study enrollment) * Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed) * Creatine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows: * ≤ 0.8 mg/dL (for patients 3 to 5 years of age) * ≤ 1.0 mg/dL (for patients 6 to 9 years of age) * ≤ 1.2 mg/dL (for patients 10 to 12 years of age) * ≤ 1.4 mg/dL (for female patients ≥ 13 years of age) * ≤ 1.5 mg/dL (for male patients 13 to 15 years of age) * ≤ 1.7 mg/dL (for male patients ≥ 16 years of age) * Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN) * SGPT ≤ 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L) * Serum albumin ≥ 2 g/dL * Oxygen saturation \> 92% on room air * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator * Completely toilet trained * No chronic diarrhea or urinary incontinence during the day or night, , and no in-dwellling urinary catheters * No uncontrolled infection * No known pregnant member of the household PRIOR CONCURRENT THERAPY: * Fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy * At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis * At least 3 months since prior stem cell transplantation or rescue (without TBI) * No evidence of active graft-vs-host disease * At least 6 weeks since other prior substantial bone marrow radiotherapy or treatment with therapeutic doses of MIBG * More than 3 weeks since prior myelosuppressive chemotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * More than 7 days since prior growth factor(s) that support platelet or white blood cell number or function * At least 7 days since prior biologic agents * At least 3 half-lives since prior monoclonal antibodies * More than 7 days since prior viral immunizations, including influenza * At least 42 days since the completion of any type of immunotherapy, e.g., tumor vaccines * No other viral immunizations after enrolling on study until 28 days after their last planned Seneca Valley virus-001 infusion or until documented viral clearance, whichever is longest * Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for the past 7 days * No other concurrent investigational drugs * No other concurrent anticancer agents (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy) * Prior treatment with Seneca Valley virus-001 is not allowed
References
Publications (0)
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