Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

Part of paid clinical trials in Castro Valley, California.

Sponsor
NewLink Genetics Corporation
Study ID
NCT02052648
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme
  • Glioma
  • Gliosarcoma
  • Malignant Brain Tumor

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indoximod — DRUG
  • Temozolomide — DRUG
  • Bevacizumab — DRUG
  • Stereotactic Radiation — RADIATION

Study Details

In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.

Key Dates

First listed
Feb 3, 2014
Start date
Mar 31, 2014
Status verified
Feb 2024
Primary completion
Apr 18, 2018
Completion
Jun 20, 2019

Study Design

Enrollment
160 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b Cohort 1
    Phase 1B patients will receive Indoximod given in escalating doses. Initial dosing will be 600 mg BID by mouth with escalation planned to 1200 mg BID by mouth. The medication should be taken twice daily for 28 days each cycle. Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days at all dosing levels of indoximod. Each cycle is 28 days. Patients will continue until they experience disease progression or toxicity.
  • Experimental: Cohort 2a
    Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
  • Experimental: Cohort 2b
    Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
  • Experimental: Cohort 2c
    Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.

Primary Outcome Measure

Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects [ Time Frame: 3 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
Eden Medical CenterCastro ValleyCalifornia94546-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
UC Irvine Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Moffitt Cancer CenterTampaFlorida33612-
University Cancer and Blood CenterAthensGeorgia30607-
Children's Healthcare of AtlantaAtlantaGeorgia30342-
Augusta UniversityAugustaGeorgia30912-
University of ChicagoChicagoIllinois60637-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of KentucyLexingtonKentucky40536-
John Nasseff Neuroscience InstituteMinneapolisMinnesota55407-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Wake Forest Baptist Health Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Penn State Hershey Medical CenterHersheyPennsylvania17033-
Texas OncologyAustinTexas78705-
Huntsman Cancer CenterSalt Lake CityUtah84112-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Castro Valley, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Eden Medical Center· Castro Valley, CACedars-Sinai Medical Center· Los Angeles, CAUC Irvine Chao Family Comprehensive Cancer Center· Orange, CAMoffitt Cancer Center· Tampa, FLUniversity Cancer and Blood Center· Athens, GAChildren's Healthcare of Atlanta· Atlanta, GA

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