RECRUITING

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

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Conditions

Locally Advanced Rectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

DINOMITE (Decreasing Hypoxia With Mitochondrial Inhibition in Locally Advanced Rectal Cancer): Phase 1 Trial of Papaverine in Combination With Radiation

Quick Facts

Study Start:2025-06-06
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06834126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * 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
  3. * Age: ≥ 18 years
  4. * Eastern Cooperative Oncology Group (ECOG) ≤ 2
  5. * Histologically confirmed rectal adenocarcinoma
  6. * Patient wants to pursue an organ preservation/non-operative management (NOM) approach after completion of total neoadjuvant therapy (TNT)
  7. * Locally advanced rectal cancer (T3-4 or node+, M0)
  8. * Tumor is microsatellite stable (MSS) (defined as not microsatellite instability-high \[MSI-H\] or mismatch repair deficient \[dMMR\])
  9. * 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
  10. * 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
  11. * 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
  12. * Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 30 days of start)
  13. * Aspartate aminotransferase (AST) =\< 2.5 x ULN (within 30 days of start)
  14. * Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 30 days of start)
  15. * Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days of start)
  16. * 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)
  17. * 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)
  18. * 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
  19. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
  1. * Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy
  2. * Prior pelvic irradiation resulting in overlapping fields
  3. * Use of levodopa in the last 30 days
  4. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  5. * Unable to undergo MRI and endoscopic procedures
  6. * History of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism
  7. * 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
  8. * Females only: Pregnant or breastfeeding
  9. * 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
  10. * 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)

Contacts and Locations

Principal Investigator

Terence M Williams
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-06
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2025-06-06
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

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