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

Completed · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor

In brief

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 facts

Study ID

NCT02052648

Run by

NewLink Genetics Corporation

People needed

160

Starts

2014-03-01

Expected to finish

2019-06-20

Last updated by the study team

2024-03-27

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven intracranial glioblastoma multiforme (WHO grade IV glioma) or gliosarcoma. In addition, the Phase 1b cohort will include patients with progressive WHO grade III glioma.
• Patients will be eligible if the original histology was lower grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made.
• Unequivocal radiographic evidence for tumor progression by MRI. It is understood that some patients may be resected prior to enrolling onto protocol
• Patients must have completed a course of radiation therapy and at least 2 adjuvant cycles of temozolomide for the phase 2 component.
• Patients enrolling onto Cohort 2b who have been taken off bevacizumab must have had at least a 28 day washout from any previous administration of bevacizumab. It is preferred that patients who fail bevacizumab prior to trial entry remain on bevacizumab in the trial.
• Prior temozolomide is not required for the phase 1 component; prior radiation is required for the phase 1 arm.
• Patients must be on a steroid dose less than or equal to 2 mg of dexamethasone daily (or equivalent), and this dose must not have increased for at least 14 days prior to obtaining the enrollment.
• ECOG performance status ≤1 or Karnofsky ≥70%.
• Age between 16
• Must be 28 days from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
• Must be 14 days from administration of non-cytotoxic agents (e.g., bevacizumab (except COHORT 2b), interferon, tamoxifen, thalidomide, cis-retinoic acid, tyrosine kinase inhibitor, etc.).

You may not qualify if…

• Prior invasive malignancy that is not low-grade glioma, high-grade glioma, glioblastoma, or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years.
• Patients on the phase 2 portion of the study may not have more than 2 prior regimens for recurrent disease for glioblastoma/gliosarcoma. Patients on the phase 1 portion of the study may not have had more than 3 prior regimens.
• Systemic corticosteroid therapy > 2 mg of dexamethasone daily (or equivalent) at study enrollment.
• Active or history of autoimmune disease

Where it is running

• Eden Medical Center — Castro Valley, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC Irvine Chao Family Comprehensive Cancer Center — Orange, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University Cancer and Blood Center — Athens, Georgia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucy — Lexington, Kentucky, United States
• John Nasseff Neuroscience Institute — Minneapolis, Minnesota, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• Wake Forest Baptist Health Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Texas Oncology — Austin, Texas, United States
• Huntsman Cancer Center — Salt Lake City, Utah, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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