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DINOMITE Trial: Papaverine with Radiation for Rectal Cancer

This study, called the DINOMITE trial, is looking at a drug called papaverine (PPV) given along with radiation therapy (RT) for locally advanced rectal cancer. This is cancer that has spread to nearby tissue or lymph nodes. Researchers want to find the best dose of papaverine and see how safe it is when combined with radiation. Papaverine is an enzyme inhibitor, meaning it might stop cancer cells from growing by blocking certain enzymes. Radiation uses high-energy rays to kill cancer cells. The study aims to see if this combination is safe and effective. You would need to be at least 18 years old and willing to provide blood, tissue, and stool samples, and have fMRI scans.

Study design
This is an interventional study with a planned enrollment of 36 participants. It is a Phase I trial, meaning it focuses on finding the best dose and side effects.
What's involved
You would undergo blood and tissue sample collection, CT scans, fMRI scans, and endoscopy. You would also receive consolidation therapy with mFOLFOX6 or CAPOX.
Compensation
Not stated in the trial record.
Follow-up
The study will assess side effects up to 12 months from the start of consolidation chemotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06834126

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~36 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyConsolidation TherapyFunctional Magnetic Resonance ImagingGastrointestinal EndoscopyMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute dose limiting toxicity (DLT)
Measured over From time of single-agent papaverine (PPV) week 0 treatment to start of consolidation chemotherapy (CC), assessed up to 4 weeks
+3 more outcomes measured

Conditions

Locally Advanced Rectal Adenocarcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Terence M Williams · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Terence M. Williams
[email protected]
626-218-2332
Email the study team

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Eligibility criteria

Inclusion

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 \[dMMR\])
Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 (within 30 days of start). NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
Platelets ≥ 100,000/mm\^3 (within 30 days of start). NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
Hemoglobin ≥ 9g/dL (within 30 days of start). NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 30 days of start)
Aspartate aminotransferase (AST) =\< 2.5 x ULN (within 30 days of start)
Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 30 days of start)
Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days of start)
For patients with known infections only: seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial (within 28 days of start)
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 30 days of start)
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

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
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

What this trial measures

  • Acute dose limiting toxicity (DLT)From time of single-agent papaverine (PPV) week 0 treatment to start of consolidation chemotherapy (CC), assessed up to 4 weeks

    As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. A defined adverse event considered to be possibly, probably, or definitely related to study treatment (radiation therapy or PPV). Will employ the time-to-event Bayesian optimal interval design (TITE-BOIN) to find the maximum tolerated dose (MTD).

  • Late DLTFrom the start of CC week 5 treatment to 12 months from week 0

    As assessed by NCI CTCAE v5.0. A defined adverse event considered to be possibly, probably, or definitely related to study treatment (radiation therapy or PPV). Will employ the TITE-BOIN design to find the MTD.

  • Incidence of treatment related adverse events during acute DLT periodFrom time of single-agent PPV week 0 treatment to start of CC, assessed up to 4 weeks

    As assessed by NCI CTCAE v5.0. Will be delineated by grade and attribution. A defined adverse event considered to be possibly, probably, or definitely related to study treatment (radiation therapy or PPV).

  • Incidence of treatment related adverse events during late DLT periodFrom the start of CC week 5 treatment to 12 months from week 0

    As assessed by NCI CTCAE v5.0. Will be delineated by grade and attribution. A defined adverse event considered to be possibly, probably, or definitely related to study treatment (radiation therapy or PPV).