Triapine + Chemoradiation for Cervical or Vaginal Cancer

Recruiting at 17 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Methemoglobinemia medications

Disqualifiers: Prior malignancy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5-6 weeks

21 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Sarah E Taylor

Principal Investigator

University of Pittsburgh Cancer Institute LAO

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive triapine in combination with cisplatin and radiation therapy for cervical or vaginal cancer

5-6 weeks

5 visits per week for radiation, weekly visits for cisplatin administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and FDG-PET/CT scans

3 months

Regular imaging and clinical assessments

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 4 years and 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Brachytherapy
• Cisplatin
• External Beam Radiation Therapy
• High-Dose Rate Brachytherapy
• Intensity-Modulated Radiation Therapy
• Triapine

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union 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 United States 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 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+