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OncoMatch/Clinical Trials/NCT04337177

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors

Is NCT04337177 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including VAL-413 and Temozolomide for solid tumors.

Phase 1RecruitingValent Technologies, LLCNCT04337177Data as of May 2026

Treatment: VAL-413 · Temozolomide — A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Neuroblastoma

Rhabdomyosarcoma

Sarcoma

Glioblastoma

Prior therapy

Cannot have received: irinotecan

Exception: allowed if no disease progression while receiving

patients must not have had disease progression while receiving either irinotecan, vincristine or temozolomide

Cannot have received: vincristine

Exception: allowed if no disease progression while receiving

patients must not have had disease progression while receiving either irinotecan, vincristine or temozolomide

Cannot have received: temozolomide

Exception: allowed if no disease progression while receiving

patients must not have had disease progression while receiving either irinotecan, vincristine or temozolomide

Cannot have received: allogeneic stem cell transplant

Patients who have had allogeneic transplants are ineligible.

Lab requirements

Blood counts

Peripheral ANC ≥ 1,000/µL; Platelet count ≥100,000/µL (transfusion independent); Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions)

Kidney function

Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m2 or Serum creatinine based on age/gender as specified

Liver function

Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 5 x ULN for age; Serum albumin ≥ 2 g/dL

Peripheral absolute neutrophil count (ANC) ≥ 1,000/µL; Platelet count ≥100,000/µL (transfusion independent); Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions); Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m2 or Serum creatinine based on age/gender as specified; Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 5 x ULN for age; Serum albumin ≥ 2 g/dL

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCSF, Mission Bay - Benioff Children's Hospital · San Francisco, California
  • Children's National Research Institute - Children's National Hospital · Washington D.C., District of Columbia
  • Indiana University School of Medicine, Riley Hospital for Children · Indianapolis, Indiana
  • University of North Carolina at Chapel Hill - North Carolina Cancer Hospital · Chapel Hill, North Carolina
  • Atrium Health Levine Children's Hospital - Carolinas Medical Center · Charlotte, North Carolina

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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