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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06834126
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and tissue sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Consolidation Therapy — DRUG
    Receive CC with mFOLFOX6 or CAPOX
  • Functional Magnetic Resonance Imaging — PROCEDURE
    Undergo fMRI
  • Gastrointestinal Endoscopy — PROCEDURE
    Undergo endoscopy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Papaverine — DRUG
    Given IV
  • Radiation Therapy — RADIATION
    Undergo RT
  • Total Mesorectal Excision — PROCEDURE
    Undergo ToME

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Jul 2025
Primary completion
Sep 19, 2028
Completion
Sep 19, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1 (RT, CC)
    Patients undergo RT QD on days 1-5 (Monday-Friday) of week 1. Starting at week 5, patients receive SOC CC with either mFOLFOX6 or CAPOX for 3-4 months in the absence of disease progression or unacceptable toxicity. As early as four weeks following completion of CC, patients with persistent disease (non-cCR) or disease recurrence in the rectum during disease evaluation may undergo ToME. Additionally, patients undergo one fMRI on study as well as CT, MRI, endoscopy, and blood and tissue sample collection throughout the trial.
  • Experimental: Cohort 2 (PPV, RT, CC)
    Patients receive PPV IV over 15-30 minutes on day -3 of week 0 and days 1-5 of week 1. Patients also undergo RT QD on days 1-5 (Monday-Friday) of week 1, 1-2 hours after PPV. Starting at week 5, patients receive SOC CC with either mFOLFOX6 or CAPOX for 3-4 months in the absence of disease progression or unacceptable toxicity. As early as four weeks following completion of CC, patients with persistent disease (non-cCR) or disease recurrence in the rectum during disease evaluation may undergo ToME. Additionally, patients undergo two fMRI on study as well as CT, MRI, endoscopy, and blood and tissue sample collection throughout the trial.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Terence M. Williams
[email protected]
626-218-2332
Terence M. Williams (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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