Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01711515
Phase
PHASE1
Status
Completed

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • Stage IB2 Cervical Cancer AJCC v6 and v7
  • Stage II Cervical Cancer AJCC v7
  • Stage IIA Cervical Cancer AJCC v7
  • Stage IIB Cervical Cancer AJCC v6 and v7
  • Stage IIIB Cervical Cancer AJCC v6 and v7
  • Stage IVA Cervical Cancer AJCC v6 and v7

Eligibility Criteria

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

Interventions

  • Cisplatin — DRUG
    Given IV
  • External Beam Radiation Therapy — RADIATION
    Undergo external beam radiation therapy
  • Internal Radiation Therapy — RADIATION
    Undergo intracavitary brachytherapy
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of ipilimumab when given after chemoradiation therapy in treating patients with stages IB2-IIB or IIIB-IVA cervical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as ipilimumab, may find tumor cells and help carry tumor-killing substances to them. Giving ipilimumab together with chemoradiation therapy may be a better way treat cervical cancer.

Key Dates

Start date
Oct 1, 2012
Status verified
Aug 2020
Primary completion
Feb 9, 2017
Completion
Jul 17, 2020

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cisplatin, radiation therapy, and ipilimumab)
    Patients receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36, undergo extended beam radiation therapy 5 days a week for 6 weeks, and then undergo intracavitary brachytherapy for approximately 2 weeks. Within 2 weeks, patients receive ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks.

Primary Outcome Measure

DLTs occurring during adjuvant ipilimumab in the dose escalation phase [ Time Frame: During first 2 courses of treatment ]

Locations (16)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Hartford HospitalHartfordConnecticut06102-
The Hospital of Central ConnecticutNew BritainConnecticut06050-
Augusta University Medical CenterAugustaGeorgia30912-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87102-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic FoundationClevelandOhio44195-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Women and Infants HospitalProvidenceRhode Island02905-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Los Angeles, CA

By research site
Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAHartford Hospital· Hartford, CTThe Hospital of Central Connecticut· New Britain, CT

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