Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Documentation of disease
- Histologic documentation: Histologically-proven advanced (metastatic or
unresectable primary) pheochromocytoma or paraganglioma
- Stage: Advanced (metastatic or unresectable primary) disease
- Tumor site: Histologically-proven pheochromocytoma or paraganglioma
- Radiographic evaluation: Radiographic evidence of disease progression by Response
Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in the 12 months
prior to registration
- Measurable disease
- Lesions must be accurately measured in at least one dimension (longest diameter
to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm for lymph nodes).
Non-measurable disease includes disease smaller than these dimensions or lesions
considered truly non-measurable including: leptomeningeal disease, ascites,
pleural or pericardial effusion, lymphangitic involvement of skin or lung
- Prior treatment with other somatostatin analog, 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 metaiodobenzylguanidine (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)
- Not pregnant and not nursing, because this study involves an agent that has known
genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing
potential only, a negative pregnancy test done =< 7 days prior to registration is
required
- Contraception
- Therapy utilized in this trial is associated with medium/high fetal risk
- Women of childbearing potential and their partners, who are sexually active, must
agree to use two highly effective forms of contraception in combination. This
should be started from the time of registration and continue throughout the
period of taking study treatment and for at least 1 month after last dose of
study drug(s), or they must totally/truly abstain from any form of sexual
intercourse
- Male patients must use a condom during treatment and for 3 months after the last
dose of study drug(s) when having sexual intercourse with a pregnant woman or
with a woman of childbearing potential. Female partners of male patients should
also use a highly effective form of contraception if they are of childbearing
potential. Male patients should not donate sperm throughout the period of taking
study drug(s) and for 3 months following the last dose of study drug(s)
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 10 mg/dL if prior radionuclide therapy Hemoglobin >= 8 mg/dL if no prior
radionuclide therapy
- In the absence of transfusion within the previous 24 hours. Radionuclide therapy
includes PRRT or MIBG
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Except in the case of Gilbert's syndrome, then total bilirubin must be =< 3.0 x
ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN
- Creatinine < 1.5 x ULN OR calculated (calc.) creatinine clearance > 50 mL/min
- Calculated by Cockcroft-Gault equation
- No indication of uncontrolled, potentially reversible cardiac condition(s) as
determined by investigator (e.g., unstable ischemia, uncontrolled symptomatic
arrhythmia, congestive heart failure, Fridericia's formula-corrected QT interval
[QTcF] prolongation > 500 msec, electrolyte disturbances, etc.) and no known
congenital long QT syndrome
- No extensive bilateral lung disease or pneumonitis
- No abnormal organ or bone marrow function =< 28 days prior to registration
- Patients with human immunodeficiency virus (HIV) positivity are allowed if CD4 count >
250 cells/uL and they have an undetectable HIV viral load within 6 months of
registration
- No active infection
- No history of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology
suggestive of MDS) or acute myeloid leukemia
- No known gastrointestinal condition(s) that might predispose for drug intolerability
or poor drug absorption
- No known medical condition causing an inability to swallow oral formulations of agents
- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to PARP inhibitors
- 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