21 Participants Needed

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

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?

SE

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
See 13 more

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.
See 7 more

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?
1Treatment groups
Experimental Treatment
Group I: Treatment (triapine, chemoradiation)Experimental Treatment12 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:

πŸ‡ͺπŸ‡Ί
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
πŸ‡ΊπŸ‡Έ
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
πŸ‡¨πŸ‡¦
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
πŸ‡―πŸ‡΅
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security