Actively Recruiting
Papaverine Combined With Radiation Therapy for Locally Advanced Rectal Cancer Decreasing Hypoxia With Mitochondrial Inhibition: Phase 1 DINOMITE Trial
Led by City of Hope Medical Center ยท Updated on 2025-07-18
36
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating papaverine (PPV) combined with radiation therapy (RT) for treating patients with locally advanced rectal cancer that has spread to nearby tissues or lymph nodes. This phase I trial aims to find the best dose of PPV with RT, assess safety and tolerability, and explore how well the combination works. The study also investigates whether this combination reduces tumor hypoxia, affects the tumor immune environment, and identifies biomarkers predicting patient responses. The trial includes two groups: one receiving standard RT followed by consolidation chemotherapy (CC) with mFOLFOX6 or CAPOX, and the other receiving PPV intravenously before and during RT, then the same chemotherapy. Radiation is given once daily Monday to Friday during week 1. After chemotherapy, some patients with persistent or recurrent disease may undergo total mesorectal excision (ToME). Imaging scans like functional MRI, CT, MRI, endoscopy, and blood and tissue samples are collected throughout the study. Participants are monitored closely during treatment and followed up every three months for two years, then every six months for three more years. Researchers will measure side effects during and after treatment, treatment response rates, survival outcomes, and disease recurrence. The study includes detailed assessments through scans, biopsies, and laboratory tests to understand treatment effects and patient safety over time.
CONDITIONS
Brief 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
- Willingness to participate in all correlative studies including imaging and tissue collection
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Histologically confirmed rectal adenocarcinoma
- Desire to pursue organ preservation or non-operative management after therapy
- Locally advanced rectal cancer (T3-4 or node positive, M0)
- Tumor is microsatellite stable (MSS)
- Adequate blood counts and organ function within 30 days of start
- Viral load undetectable if infected with HIV, hepatitis B or C
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during the study and 4 months after
You will not qualify if you...
- Chemotherapy, biological therapy, or immunotherapy within 14 days before starting study treatment
- Prior pelvic radiation overlapping study fields
- Use of levodopa in the last 30 days
- History of allergic reactions to similar compounds
- Unable to undergo MRI or endoscopic procedures
- History of complete atrioventricular block, liver dysfunction, or priapism
- Other active malignancy that interferes with study
- Pregnant or breastfeeding women
- Any condition that poses safety concerns or prevents compliance with study procedures
- Investigator judgment that participant may not comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 5 months
Participants receive radiation therapy (RT) once daily on weekdays of week 1. Some participants also receive papaverine (PPV) intravenously before and during RT. Starting at week 5, participants receive standard chemotherapy (mFOLFOX6 or CAPOX) for 3 to 4 months, unless disease progresses or unacceptable toxicity occurs. Throughout treatment, participants undergo imaging, endoscopy, and blood and tissue sample collection.
Daily visits for RT during week 1; chemotherapy visits weekly or as scheduled for 3 to 4 months; multiple imaging and sample collection visits during treatment
Duration - Up to 5 years
After completing treatment, participants are followed up every 3 months for 2 years and then every 6 months for an additional 3 years to monitor health and disease status.
Follow-up visits every 3 months for 2 years, then every 6 months for 3 years
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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