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

February 23, 2021

Clinical Trial Information

Protocol – Alliance – A021804

SCHEMA A021804

Please Note – Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma.
  2. 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.
  3. Measurable disease.
  4. 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).
  5. Age ≥ 18 years.
  6. ECOG Performance Status: 0-2.
  7. 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.

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