A Prospective, Multi-Institutional Phase II Evaluating Temozolomide Vs. Temozolomide and Olaparib for Advanced Pheochromocytoma and Paraganglioma

Protocol – Alliance – A021804

SCHEMA A021804

Please Note – Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma.
2. Advanced (metastatic or unresectable primary) disease.
3. Histologically-proven pheochromocytoma or paraganglioma.
4. Radiographic evidence of disease progression by RECIST v1.1 criteria in the 12 months prior to registration.
5. Measurable disease.
6. Prior treatment with other chemotherapy, radiotherapy (including peptide radionuclide receptor therapy [PRRT]), or surgery must be completed ≥ 28 days prior to registration. Patients must have recovered from any effects of any major surgery prior to registration.  Prior treatment with radiolabeled MIBG must be completed ≥ 12 weeks prior to registration and lifetime cumulative 131I-MIBG dose must be < 1000 MBq kg-1 (36 mCi kg-1).  No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor.
7. Must me at least 18 years of age.
8. ECOG Performance Status 0-2.
9. Concurrent use of combination antiretroviral therapy (ART) is not permitted.