Combination of Study Drug (Indoximod) with Temozolomide (Temodar) for Adults with Temodar Refractory Brain Tumors

What we are studying

This study is being done to test the feasibility of combining the approved drug therapy temozolomide (Temodar) with an experimental drug called indoximod. Temozolomide is an oral medicine that is approved for commercial use as a prescribed drug by the FDA for the treatment of brain cancer. The experimental (study) drug, indoximod, is an oral medication that blocks an enzyme (a type of protein that affects other proteins in the body) called IDO. Doctors think that tumors use IDO to escape attack by your body’s immune system. By blocking this IDO enzyme, indoximod may help your body attack the tumor cells more effectively. Indoximod given along with various chemotherapy agents such as Temozolomide may increase the effectiveness of the chemotherapy.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Diagnosed with brain cancer (glioblastoma multiform or gliosarcoma)
  • Disease progression
  • Completed a course of radiation therapy and completed 2 cycles of Temodar
  • Normal organ function
  • Life expectancy > 6 months
  • No active infections
  • Cannot be pregnant or breastfeeding

What is involved

  • Physical exam and labs every 2 weeks during treatment
  • MRI every 8 weeks
  • Treatment with indoximod and Temodar (+ bevacuizumab or stereotactic radiation therapy)


Subjects will not be paid to take part in this research study. However, the Comprehensive Cancer Center of Wake Forest University will provide a parking voucher for study related visits.

Contact Information

Study Coordinator
Jill Weber Pfefferkorn
Principal Investigator
Glenn Lesser, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.