Actively Recruiting
Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial
Led by City of Hope Medical Center · Updated on 2025-07-18
36
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent provided by participant or legal representative
- Willingness to participate in all correlative studies including fMRI and tissue, blood, and stool collection
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed rectal adenocarcinoma
- Desire for organ preservation or non-operative management after total neoadjuvant therapy
- Locally advanced rectal cancer classified as T3-4 or node positive, no distant metastasis
- Tumor is microsatellite stable (not MSI-high or mismatch repair deficient)
- Absolute neutrophil count of at least 1,500/mm^3 within 30 days before starting treatment
- Platelet count of at least 100,000/mm^3 within 30 days before starting treatment
- Hemoglobin level of at least 9 g/dL within 30 days before starting treatment
- Total bilirubin less than or equal to 1.5 times the upper limit of normal within 30 days before treatment
- AST and ALT levels less than or equal to 2.5 times the upper limit of normal within 30 days before treatment
- Creatinine clearance at least 50 mL/min within 30 days before treatment
- For patients with HIV, hepatitis B or C infections: undetectable viral load and stable on therapy if applicable
- Women of childbearing potential must have a negative pregnancy test within 30 days before treatment
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for 4 months after last treatment
You will not qualify if you...
- Chemotherapy, biological therapy, or immunotherapy within 14 days or five half-lives before starting the trial
- Prior pelvic radiation causing overlapping treatment areas
- Use of levodopa within the last 30 days
- History of allergic reactions to similar compounds as papaverine
- Unable to undergo MRI or endoscopic procedures
- History of complete atrioventricular block, liver dysfunction such as cirrhosis, or priapism
- Presence of other active cancers unless unlikely to interfere with the study
- Pregnant or breastfeeding women
- Any other condition that makes participation unsafe or not feasible according to the investigator
- Inability to comply with all study procedures and visit schedules
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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