ACTIVE_NOT_RECRUITING

Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-17
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04394858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documentation of disease
  2. * Histologic documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma
  3. * Stage: Advanced (metastatic or unresectable primary) disease
  4. * Tumor site: Histologically-proven pheochromocytoma or paraganglioma
  5. * 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
  6. * Measurable disease
  7. * 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
  8. * 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
  9. * 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)
  10. * Prior treatment with antibiotics must be completed \>= 7 days prior to registration
  11. * No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor
  12. * No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
  13. * 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
  14. * Contraception
  15. * Therapy utilized in this trial is associated with medium/high fetal risk
  16. * 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
  17. * 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)
  18. * Age \>= 12 years
  19. * Eastern Cooperative Oncology Group (ECOG) Patients ≥ 18 years of age: Performance status: 0-2
  20. * Patients \< 16 years of age: Lansky ≥ 50%
  21. * Patients 16 to \< 18 years of age: Karnofsky ≥ 50%
  22. * Patients ≥ 18 years of age: ECOG performance status ≤ 2
  23. * Absolute neutrophil count \>= 1,500/mm\^3
  24. * Platelet count \>= 100,000/mm\^3
  25. * Hemoglobin \>= 10 mg/dL if prior radionuclide therapy Hemoglobin \>= 8 mg/dL if no prior radionuclide therapy
  26. * In the absence of transfusion within the previous 24 hours. Radionuclide therapy includes PRRT or MIBG
  27. * Total bilirubin =\< 1.5 x upper limit of normal (ULN)
  28. * Except in the case of Gilbert's syndrome, then total bilirubin must be =\< 3.0 x ULN
  29. * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN
  30. * Creatinine \< 1.5 x ULN OR calculated (calc.) creatinine clearance \> 50 mL/min
  31. * Calculated by Cockcroft-Gault equation
  32. * By Cockcroft-Gault equation. Alternatively, for patients \< 18 years of age, maximum serum creatinine ≤ the below age-gender-specific norms:
  33. * Age 12 years: Male 1.2; female 1.2
  34. * Age 13 to \< 16 years: Male 1.5; female 1.4
  35. * Age 16 to \< 18 years: Male 1.7; female 1.4
  36. * 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
  37. * No extensive bilateral lung disease or pneumonitis
  38. * No abnormal organ or bone marrow function =\< 28 days prior to registration
  39. * 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
  40. * No active infection
  41. * No history of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia
  42. * No known gastrointestinal condition(s) that might predispose for drug intolerability or poor drug absorption
  43. * No known medical condition causing an inability to swallow oral formulations of agents
  44. * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PARP inhibitors
  45. * Concurrent use of combination antiretroviral therapy (ART) is not permitted
  46. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jaydira Del Rivero
PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology

Study Locations (Sites)

Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
United States
Anchorage Oncology Centre
Anchorage, Alaska, 99508
United States
Katmai Oncology Group
Anchorage, Alaska, 99508
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Caro Cancer Center
Caro, Michigan, 48723
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
United States
Henry Ford River District Hospital
East China Township, Michigan, 48054
United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
United States
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Hope Cancer Clinic
Livonia, Michigan, 48154
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044
United States
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044
United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453
United States
Hope Cancer Center
Pontiac, Michigan, 48341
United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341
United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
United States
Henry Ford Rochester Hospital
Rochester Hills, Michigan, 48309
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312
United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764
United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088
United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093
United States
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, 48093
United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093
United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093
United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661
United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Cambridge Medical Center
Cambridge, Minnesota, 55008
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Unity Hospital
Fridley, Minnesota, 55432
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Health Partners Inc
Minneapolis, Minnesota, 55454
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
New Ulm Medical Center
New Ulm, Minnesota, 56073
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Ridgeview Medical Center
Waconia, Minnesota, 55387
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Albany Medical Center
Albany, New York, 12208
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Saint Charles Health System
Bend, Oregon, 97701
United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
United States
Bay Area Hospital
Coos Bay, Oregon, 97420
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
Farmington Health Center
Farmington, Utah, 84025
United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
United States
Providence Regional Cancer Partnership
Everett, Washington, 98201
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
United States
Pacific Gynecology Specialists
Seattle, Washington, 98104
United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122
United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
United States
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
United States
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Jaydira Del Rivero, PRINCIPAL_INVESTIGATOR, Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-17
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2021-03-17
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • 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