Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This 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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ Documented informed consent of the participant and/or legally authorized representative
- ✓ Willingness to participate in all correlative studies: fMRI, and tissue collection of tumor and normal rectum (ribonucleic acid \[RNA\]/deoxyribonucleic acid \[DNA\]/protein), blood (plasma/peripheral blood mononuclear cell \[PBMC\]) draws and stool collection
- ✓ Age: ≥ 18 years
- ✓ Eastern Cooperative Oncology Group (ECOG) ≤ 2
- ✓ Histologically confirmed rectal adenocarcinoma
- ✓ Patient wants to pursue an organ preservation/non-operative management (NOM) approach after completion of total neoadjuvant therapy (TNT)
- ✓ Locally advanced rectal cancer (T3-4 or node+, M0)
- ✓ Tumor is microsatellite stable (MSS) (defined as not microsatellite instability-high \[MSI-H\] or mismatch repair deficient \[dMMR\])
You may not qualify if…
- ✕ Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy
- ✕ Prior pelvic irradiation resulting in overlapping fields
- ✕ Use of levodopa in the last 30 days
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- ✕ Unable to undergo MRI and endoscopic procedures
- ✕ History of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism
- ✕ Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- ✕ Females only: Pregnant or breastfeeding
Where it's recruiting
Duarte
Source: ClinicalTrials.gov · NCT06834126 · last updated 2026-07-22