Triapine + Chemoradiation for Cervical or Vaginal Cancer

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen by Sarah E Taylor

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells.

Research Team

Sarah E Taylor

Principal Investigator

University of Pittsburgh Cancer Institute LAO

Eligibility Criteria

This trial is for adults with stage IB2-IVA cervical or vaginal cancer who can take oral meds, have a life expectancy over 6 months, and proper liver/kidney function. They must not be pregnant/breastfeeding and agree to use contraception. Excluded are those with recent cancers (except certain skin/cervical cancers), prior pelvic radiation, G6PD deficiency, uncontrolled diabetes or other serious illnesses.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

Platelets >= 100 x 10^9/L

Able to understand and willingness to sign a written informed consent document

Exclusion Criteria

I do not have a G6PD deficiency.

My diabetes is under control with medication, and my fasting blood sugar is <= 200 mg/dL.

I have not had, nor am I planning to have, a hysterectomy as part of my cervical cancer treatment.

Treatment Details

Interventions

• Brachytherapy (Radiation)
• Cisplatin (Alkylating agents)
• External Beam Radiation Therapy (Radiation)
• High-Dose Rate Brachytherapy (Radiation)
• Intensity-Modulated Radiation Therapy (Radiation)
• Triapine (Ribonucleotide Reductase Inhibitor)

Trial Overview The trial tests the safety and optimal dose of Triapine combined with cisplatin chemotherapy and radiation therapy in treating cervical/vaginal cancer. It explores whether adding Triapine enhances the effectiveness of standard treatments by inhibiting an enzyme needed for cancer cell growth.

Participant Groups

Group I: Treatment (triapine, chemoradiation) Experimental Treatment 12 Interventions

Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School