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OncoMatch/Clinical Trials/NCT06834126

Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial

Is NCT06834126 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Consolidation Therapy and Papaverine for locally advanced rectal adenocarcinoma.

Phase 1RecruitingCity of Hope Medical CenterNCT06834126Data as of May 2026

Treatment: Consolidation Therapy · PapaverineThis phase I trial studies the side effects and best dose of papaverine (PPV) when given together with radiation therapy (RT) and tests how well it works in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). PPV is an enzyme inhibitor, and it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving PPV with RT may be safe, tolerable, and/or effective in treating patients with locally advanced rectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage II, III

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: chemotherapy

Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy

Cannot have received: biological therapy

Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy

Cannot have received: immunotherapy

Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy

Cannot have received: radiation therapy

Exception: prior pelvic irradiation resulting in overlapping fields

Prior pelvic irradiation resulting in overlapping fields

Lab requirements

Blood counts

ANC ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9g/dL (within 30 days of start)

Kidney function

Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days of start)

Liver function

Total bilirubin ≤ 1.5 X ULN; AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN (within 30 days of start)

ANC ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9g/dL; Total bilirubin ≤ 1.5 X ULN; AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Creatinine clearance of ≥ 50 mL/min

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

US trial sites

  • City of Hope Medical Center · Duarte, California

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

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