A Phase II Study of Temozolomide and Olaparib to Treat Advanced Pheochromocytoma and Paraganglioma

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A Prospective, Multi-Institutional Phase II Trial Evaluating Temozolomide vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and Paraganglioma (A021804) (CIRB)

Purpose

In this study, researchers are assessing the safety and effectiveness of adding olaparib to temozolomide treatment for patients with metastatic or inoperable neuroendocrine cancers (pheochromocytoma or paraganglioma). Temozolomide alone is the usual treatment for these cancers. 

Olaparib is an inhibitor of PARP, a type of protein that cells use to repair DNA damage. PARP inhibitors prevent tumor cells from repairing themselves, and they may stop growing. Giving olaparib in combination with temozolomide may shrink or stabilize a cancer in patients with pheochromocytoma or paraganglioma more effectively than temozolomide alone. 

Patients will be randomly assigned to receive temozolomide alone or with olaparib. Both medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic or inoperable pheochromocytoma or paraganglioma that continues to grow.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of the study treatment. Prior treatment with temozolomide, dacarbazine, or a PARP inhibitor is not permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nitya Raj at 646-888-4849.

Protocol

20-574

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators