Clinical Trial Information
Protocol – Alliance – A021804
Please Note – Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma.
- Advanced (metastatic or unresectable primary) disease. Histologically-proven pheochromocytoma or paraganglioma and radiographic evidence of disease progression by RECIST v1.1 criteria in the 12 months prior to registration.
- Measurable disease.
- 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).
Prior treatment with antibiotics must be completed ≥ 7 days prior to registration.
No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor.
No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Age ≥ 18 years.
- ECOG Performance Status: 0-2.
- Concurrent use of combination antiretroviral therapy (ART) is not permitted.
Chronic concomitant treatment with strong or moderate CYP3A4 inducers or inhibitors is not allowed. Patients must discontinue the agent(s) ≥ 21 days prior to registration; enzalutamide and/or phenobarbital must be discontinued ≥ 5 weeks prior to registration.