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This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Poly (adenosine diphosphate [ADP]-ribose) polymerases (PARPs) are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04394858 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jaydira Del Rivero |
Principal Investigator Affiliation | Alliance for Clinical Trials in Oncology |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Advanced Adrenal Gland Pheochromocytoma, Advanced Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma, Metastatic Paraganglioma, Stage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8, Stage IV Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8, Unresectable Adrenal Gland Pheochromocytoma, Unresectable Paraganglioma |
PRIMARY OBJECTIVE:
Experimental: Arm I (temozolomide, olaparib)
Patients receive temozolomide PO QD and olaparib PO BID on days 1-7. Treatment with temozolomide repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Cycles of olaparib repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT with contrast or MRI throughout the study and undergo mandatory collection of blood samples prior to treatment. Patients may optionally undergo collection of blood samples at the time of progression.
Active Comparator: Arm II (temozolomide)
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with contrast or MRI throughout the study and undergo mandatory collection of blood samples prior to treatment. Patients may optionally undergo collection of blood samples at the time of progression.
Procedure: - Biospecimen Collection
Undergo collection of blood samples
Procedure: - Computed Tomography with Contrast
Undergo CT with contrast
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Drug: - Olaparib
Given PO
Other: - Quality-of-Life Assessment
Ancillary studies
Drug: - Temozolomide
Given PO
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Status
Suspended
Address
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Status
Recruiting
Address
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Status
Recruiting
Address
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Status
Recruiting
Address
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Status
Recruiting
Address
Memorial Sloan Kettering Commack
Commack, New York, 11725
Status
Recruiting
Address
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Recruiting
Address
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Status
Suspended
Address
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Status
Suspended
Address
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Status
Suspended
Address
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Status
Suspended
Address
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Status
Suspended
Address
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Status
Suspended
Address
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Status
Suspended
Address
Katmai Oncology Group
Anchorage, Alaska, 99508
Status
Suspended
Address
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Status
Suspended
Address
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Status
Suspended
Address
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Status
Withdrawn
Address
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Status
Suspended
Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Status
Suspended
Address
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Status
Suspended
Address
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Status
Suspended
Address
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686
Status
Suspended
Address
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
Status
Recruiting
Address
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Status
Recruiting
Address
Illinois CancerCare-Canton
Canton, Illinois, 61520
Status
Recruiting
Address
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Status
Recruiting
Address
Centralia Oncology Clinic
Centralia, Illinois, 62801
Status
Recruiting
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Recruiting
Address
Carle at The Riverfront
Danville, Illinois, 61832
Status
Recruiting
Address
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Status
Recruiting
Address
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Status
Recruiting
Address
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Status
Recruiting
Address
Crossroads Cancer Center
Effingham, Illinois, 62401
Status
Recruiting
Address
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Status
Recruiting
Address
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Status
Recruiting
Address
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Status
Recruiting
Address
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Status
Recruiting
Address
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Status
Recruiting
Address
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Status
Recruiting
Address
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Status
Recruiting
Address
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Status
Recruiting
Address
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Status
Recruiting
Address
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Status
Recruiting
Address
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Status
Recruiting
Address
Illinois CancerCare-Peru
Peru, Illinois, 61354
Status
Recruiting
Address
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Status
Recruiting
Address
Carle Cancer Center
Urbana, Illinois, 61801
Status
Recruiting
Address
Illinois CancerCare - Washington
Washington, Illinois, 61571
Status
Recruiting
Address
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Status
Recruiting
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Suspended
Address
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467
Status
Recruiting
Address
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Status
Recruiting
Address
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Status
Recruiting
Address
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Status
Recruiting
Address
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Status
Recruiting
Address
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Status
Suspended
Address
Caro Cancer Center
Caro, Michigan, 48723
Status
Recruiting
Address
Chelsea Hospital
Chelsea, Michigan, 48118
Status
Recruiting
Address
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Status
Recruiting
Address
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Status
Recruiting
Address
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Status
Recruiting
Address
Ascension Saint John Hospital
Detroit, Michigan, 48236
Status
Recruiting
Address
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, 48054
Status
Recruiting
Address
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
Status
Recruiting
Address
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Status
Recruiting
Address
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Status
Recruiting
Address
Hurley Medical Center
Flint, Michigan, 48503
Status
Recruiting
Address
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236
Status
Recruiting
Address
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
Status
Suspended
Address
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236
Status
Suspended
Address
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Status
Suspended
Address
Hope Cancer Clinic
Livonia, Michigan, 48154
Status
Recruiting
Address
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Status
Recruiting
Address
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044
Status
Suspended
Address
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, 48044
Status
Suspended
Address
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453
Status
Suspended
Address
Hope Cancer Center
Pontiac, Michigan, 48341
Status
Recruiting
Address
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341
Status
Recruiting
Address
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341
Status
Recruiting
Address
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Status
Suspended
Address
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, 48309
Status
Recruiting
Address
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601
Status
Recruiting
Address
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
Status
Recruiting
Address
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312
Status
Recruiting
Address
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764
Status
Suspended
Address
Advanced Breast Care Center PLLC
Warren, Michigan, 48088
Status
Recruiting
Address
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, 48093
Status
Suspended
Address
Macomb Hematology Oncology PC
Warren, Michigan, 48093
Status
Suspended
Address
Michigan Breast Specialists-Warren
Warren, Michigan, 48093
Status
Recruiting
Address
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093
Status
Suspended
Address
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661
Status
Recruiting
Address
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
Status
Recruiting
Address
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Status
Suspended
Address
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Status
Suspended
Address
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Status
Suspended
Address
Cambridge Medical Center
Cambridge, Minnesota, 55008
Status
Suspended
Address
Mercy Hospital
Coon Rapids, Minnesota, 55433
Status
Suspended
Address
Fairview Southdale Hospital
Edina, Minnesota, 55435
Status
Active, not recruiting
Address
Unity Hospital
Fridley, Minnesota, 55432
Status
Suspended
Address
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Status
Suspended
Address
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Status
Suspended
Address
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Status
Recruiting
Address
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Status
Suspended
Address
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Status
Suspended
Address
Health Partners Inc
Minneapolis, Minnesota, 55454
Status
Suspended
Address
Monticello Cancer Center
Monticello, Minnesota, 55362
Status
Suspended
Address
New Ulm Medical Center
New Ulm, Minnesota, 56073
Status
Suspended
Address
Fairview Northland Medical Center
Princeton, Minnesota, 55371
Status
Suspended
Address
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Status
Recruiting
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Status
Suspended
Address
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Status
Suspended
Address
Regions Hospital
Saint Paul, Minnesota, 55101
Status
Suspended
Address
United Hospital
Saint Paul, Minnesota, 55102
Status
Suspended
Address
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Status
Suspended
Address
Lakeview Hospital
Stillwater, Minnesota, 55082
Status
Suspended
Address
Ridgeview Medical Center
Waconia, Minnesota, 55387
Status
Suspended
Address
Rice Memorial Hospital
Willmar, Minnesota, 56201
Status
Suspended
Address
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Status
Suspended
Address
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Status
Recruiting
Address
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Suspended
Address
Saint Charles Health System
Bend, Oregon, 97701
Status
Suspended
Address
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Status
Recruiting
Address
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Status
Suspended
Address
Bay Area Hospital
Coos Bay, Oregon, 97420
Status
Recruiting
Address
Providence Newberg Medical Center
Newberg, Oregon, 97132
Status
Recruiting
Address
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Status
Recruiting
Address
Providence Portland Medical Center
Portland, Oregon, 97213
Status
Recruiting
Address
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Status
Not yet recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Suspended
Address
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Status
Recruiting
Address
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Status
Recruiting
Address
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Status
Suspended
Address
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Status
Suspended
Address
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Status
Recruiting
Address
Farmington Health Center
Farmington, Utah, 84025
Status
Recruiting
Address
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
Status
Recruiting
Address
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Status
Suspended
Address
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Status
Suspended
Address
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Status
Suspended
Address
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Status
Suspended
Address
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Status
Suspended
Address
Providence Regional Cancer Partnership
Everett, Washington, 98201
Status
Suspended
Address
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Status
Recruiting
Address
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Status
Suspended
Address
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Status
Suspended
Address
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Status
Suspended
Address
Pacific Gynecology Specialists
Seattle, Washington, 98104
Status
Suspended
Address
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Status
Suspended
Address
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Status
Suspended
Address
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Status
Suspended
Address
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Status
Suspended
Address
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
Status
Recruiting
Address
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Status
Suspended
Address
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Status
Suspended
Address
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
Status
Suspended
Address
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017