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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women


Advanced Adrenal Gland Pheochromocytoma;
Metastatic Paraganglioma;
Unresectable Paraganglioma

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)



Drug: Olaparib
Drug: Temozolomide

Supporting Site

National Cancer Institute


Pheochromocytomas (PHEOs) and paragangliomas (PGLs) are rare neuroendocrine tumors. Symptoms of these tumors can include hypertension, headache, palpitations, and anxiety. There are few treatments for people with advanced PHEOs and PGLs. Researchers want to see if a new drug can help.


To compare the usual chemotherapy treatment alone, temozolomide, to using the study drug, olaparib, plus the usual treatment, to see if it could shrink or stabilize these cancers.


People aged 18 years and older who have advanced (metastatic or unresectable primary) PHEOs or PGLs.


Participants will be screened with a medical record review and physical exam. They will have an electrocardiogram to assess heart function. They will have blood and urine tests.

Participants will be randomly placed into one of two groups:

-Group 1 will receive treatment in 21-day cycles. They will take temozolomide and olaparib by mouth on Days 1-7 of each cycle, for up to 13 cycles. Then they will take the study drug alone on Days 1-7 of each cycle, until their cancer gets worse.

-Group 2 will receive treatment in 28-day cycles. They will take temozolomide by mouth on Days 1-5 of each cycle, for up to 13 cycles.

Participants will keep a pill diary. They will fill out quality of life assessments. They will give copies of the imaging scans that are done as part of the usual care for their cancer. They will give blood samples for research. They will repeat some screening tests.

After treatment ends, participants will have follow-up visits in person or by phone. Participation will last for 5 years.

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- Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma

- Radiographic evidence of disease progression by RECIST v1.1 criteria in the 12 months prior to registration

- Measurable disease

- Prior treatment with other somatostatin analog, chemotherapy, radiotherapy, 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; lifetime cumulative I-MIBG dose must be < 1000 MBq kg^-1

- Prior treatment with antibiotics must be completed >= 7 days prior to registration.

- No prior treatment with temozolomide, dacarbazine, or a PARP inhibitor

- No prior allogeneic bone marrow transplant or dUCBT.

- Not pregnant and not nursing; negative pregnancy test required <= 7 days prior to registration

- Women must use two highly effective forms of contraception during and for 1 month after treatment; male patients must use a condom during and for 3 months after treatment;

- Age >= 18 years

- ECOG Performance Status: 0-2

- No indication of uncontrolled, potentially reversible cardiac condition(s) as determined by investigator 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 HIV positivity allowed if CD4 Count > 250 cells/microliter and undetectable viral load <= 6 months of reg.

- No active infection

- No history of myelodysplastic syndrome 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 composition to PARP inhibitors

- Concurrent use of combination antiretroviral therapy 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

Required Initial Laboratory Values:

Absolute Neutrophil Count: >= 1500/mm^3

Platelet Count: >= 100,000/ mm^3

Hemoglobin: >= 10 mg/dL*

Total Bilirubin: <= 1.5 x ULN**

AST/ALT: <= 3.0 x ULN

Creatinine: < 1.5 x ULN


Calc. Creatinine Clearance: > 50 mL/min

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Jaydira Del Rivero, M.D.
National Cancer Institute (NCI)
(240) 858-3851

Sarah Kelley
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44
10 Center Drive
Bethesda, Maryland 20892
(240) 753-1971

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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