Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)



Status:Recruiting
Conditions:Cancer, Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Infectious Disease, Lymphoma, Lymphoma, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:July 24, 2017
End Date:September 30, 2024

Use our guide to learn which trials are right for you!

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- A Phase 2 Subprotocol of Olaparib in Patients With Tumors Harboring Defects in DNA Damage Repair Genes

This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with
solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic
acid (DNA) damage repair genes that have spread to other places in the body and have come
back or do not respond to treatment. Olaparib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR; complete response + partial response) in
pediatric patients treated with olaparib with advanced solid tumors (including central
nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor
activating genetic alterations in the deleterious genetic alterations in the DNA damage
repair (DDR) pathway.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with olaparib with
advanced solid tumors including non-Hodgkin lymphomas, CNS tumors, and histiocytosis that
harbor deleterious genetic alterations in the DDR pathway.

II. To obtain information about the tolerability of olaparib in children and adolescents with
relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of olaparib in children and
adolescents with relapsed or refractory cancer.

TERTIARY OBJECTIVES:

I. To explore approaches to profiling changes in tumor genomics over time through the
evaluation of circulating tumor DNA.

OUTLINE:

Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28
days for 2 years in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- Patient must have enrolled onto APEC1621SC and must have been given a treatment
assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621H based on the
presence of an actionable mutation

- Patients must have a body surface area >= 0.65 m^2 at enrollment

- Patients must have radiographically measurable disease at the time of study
enrollment; patients with neuroblastoma who do not have measurable disease but have
iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in
patients with CNS involvement is defined as tumor that is measurable in two
perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than
one slice

- Note: The following do not qualify as measurable disease:

- Malignant fluid collections (e.g., ascites, pleural effusions)

- Bone marrow infiltration except that detected by MIBG scan for neuroblastoma

- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or
positron emission tomography [PET] scans) except as noted for neuroblastoma

- Elevated tumor markers in plasma or cerebrospinal fluid (CSF)

- Previously radiated lesions that have not demonstrated clear progression
post radiation

- Leptomeningeal lesions that do not meet the measurement requirements for
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

- Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16
years of age

- Note: Neurologic deficits in patients with CNS tumors must have been relatively
stable for at least 7 days prior to study enrollment; patients who are unable to
walk because of paralysis, but who are up in a wheelchair, will be considered
ambulatory for the purpose of assessing the performance score

- Patients must have fully recovered from the acute toxic effects of all prior
anti-cancer therapy and must meet the following minimum duration from prior
anti-cancer directed therapy prior to enrollment; if after the required timeframe, the
numerical eligibility criteria are met, e.g. blood count criteria, the patient is
considered to have recovered adequately

- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive

- >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy
(42 days if prior nitrosourea)

- Anti-cancer agents not known to be myelosuppressive (e.g. not associated with
reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the
last dose of agent

- Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody,
and toxicity related to prior antibody therapy must be recovered to grade =< 1

- Corticosteroids: If used to modify immune adverse events related to prior
therapy, >= 14 days must have elapsed since last dose of corticosteroid

- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting
growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for
growth factors that have known adverse events occurring beyond 7 days after
administration, this period must be extended beyond the time during which adverse
events are known to occur; the duration of this interval must be discussed with
the study chair and the study-assigned research coordinator

- Interleukins, interferons and cytokines (other than hematopoietic growth
factors): >= 21 days after the completion of interleukins, interferon or
cytokines (other than hematopoietic growth factors)

- Stem cell infusions (with or without total body irradiation [TBI]):

- Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem
cell infusion including donor lymphocyte infusion (DLI) or boost infusion:
>= 84 days after infusion and no evidence of graft versus host disease
(GVHD)

- Autologous stem cell infusion including boost infusion: >= 42 days

- Cellular therapy: >= 42 days after the completion of any type of cellular therapy
(e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)

- Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days
after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >=
50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation

- Note: Radiation may not be delivered to "measurable disease" tumor site(s)
being used to follow response to subprotocol treatment

- Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131iodine [I]-MIBG): >=
42 days after systemically administered radiopharmaceutical therapy

- Patients must not have received prior exposure to olaparib, veliparib, niraparib,
rucaparib, talazoparib or other poly adenosine diphosphate ribose polymerase
inhibitors (PARPi)

- For patients with solid tumors without known bone marrow involvement:

- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3

- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving
platelet transfusions for at least 7 days prior to enrollment)

- Patients with known bone marrow metastatic disease will be eligible for study provided
they meet the blood counts in (may receive platelet or packed red blood cells [pRBC]
transfusions provided they are not known to be refractory to red cell or platelet
transfusions); these patients will not be evaluable for hematologic toxicity

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
ml/min/1.73 m^2 or

- A serum creatinine based on age/gender as follows:

- Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for
female

- Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for
female

- Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for
female

- Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL
for female

- Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL
for female

- Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for
female

- Patients with solid tumors: bilirubin (sum of conjugated + unconjugated) =< 1.5 x
upper limit of normal (ULN) for age

- Patients with solid tumors: serum glutamic pyruvic transaminase (SGPT) (alanine
aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT
is 45 U/L)

- Patients with solid tumors: serum albumin >= 2 g/dL

- Activated partial thromboplastin time (aPTT) =< 1.5 x ULN

- International normalized ratio (INR) =< 1.5

- Patients must be able to swallow intact tablets

- All patients and/or their parents or legally authorized representatives must sign a
written informed consent; assent, when appropriate, will be obtained according to
institutional guidelines

Exclusion Criteria:

- Pregnant or breast-feeding women will not be entered on this study; pregnancy tests
must be obtained in girls who are post-menarchal; women of child-bearing potential and
their partners should agree to use two (2) highly effective forms of contraception
throughout study participation and for at least one (1) month after the last dose of
olaparib; male study participants should avoid fathering a child or donating sperm
during the study and for three (3) months after the last dose of olaparib

- Concomitant medications

- Corticosteroids: patients receiving corticosteroids who have not been on a stable
or decreasing dose of corticosteroid for at least 7 days prior to enrollment are
not eligible; if used to modify immune adverse events related to prior therapy,
>= 14 days must have elapsed since last dose of corticosteroid

- Investigational drugs: patients who are currently receiving another
investigational drug are not eligible

- Anti-cancer agents: patients who are currently receiving other anti-cancer agents
are not eligible

- Anti-GVHD agents post-transplant: patients who are receiving cyclosporine,
tacrolimus or other agents to prevent graft-versus-host disease post bone marrow
transplant are not eligible for this trial

- CYP3A/CYP3A4 agents: patients who are currently receiving drugs that are strong
and moderate inducers or inhibitors of CYP3A or CYP3A4 are not eligible; strong
inducers or inhibitors of CYP3A4 should be avoided from 21 days prior to
enrollment to the end of the study

- Patients who have an uncontrolled infection are not eligible

- Patient who are known to be serologically positive for human immunodeficiency virus
(HIV)

- Patients with known active hepatitis (i.e. hepatitis B or C)

- Patients who have received a prior solid organ transplantation are not eligible

- Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence
of brain metastases is not required; the patient can receive a stable dose of
corticosteroids before and during the study as long as these were started at least 4
weeks prior to enrollment; patients with spinal cord compression unless considered to
have received definitive treatment for this and evidence of clinically stable disease
for 28 days

- Patients with known symptomatic Fanconi anemia (FA), ataxia-telangiectasia (A-T)
syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible
(asymptomatic carriers are acceptable)

- Major surgery must not have occurred within 2 weeks prior to enrollment and patients
must have recovered from any effects of any major surgery

- Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study are not eligible
We found this trial at
95
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Nina S. Kadan-Lottick
Phone: 203-785-5702
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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4900 Mueller Boulevard
Austin, Texas 78723
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Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
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Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
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3333 Burnet Avenue # Mlc3008
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700 Childrens Drive
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7777 Forest Ln # C840
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530 Northeast Glen Oak Avenue
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401 College Street
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60 Crittenden Blvd # 70
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7700 Floyd Curl Dr
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4502 Medical Drive
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1600 Rockland Road
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401 North Broadway
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100 E Idaho St
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5841 S Maryland Ave
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1200 West Harrison Stree
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2049 E 100th St
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100 North Academy Avenue
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1600 Southwest Archer Road
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900 West Faris Rd.
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30 Prospect Ave
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705 Riley Hospital Dr
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2018 W Clinch Ave
Knoxville, Tennessee 37916
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1 Children's Way
Little Rock, Arkansas 72202
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11234 Anderson St
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600 Highland Ave
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Miami, Florida 33136
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Miami, Florida 33155
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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2525 Chicago Ave
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Nashville, Tennessee 37232
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New Brunswick, New Jersey 08903
Principal Investigator: Jocelyn A. Lewis
Phone: 732-235-8675
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New Hyde Park, New York 11040
Principal Investigator: Julie I. Krystal
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New Orleans, Louisiana 70121
Principal Investigator: Craig Lotterman
Phone: 504-703-8712
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New Orleans, Louisiana 70118
Principal Investigator: Lolie C. Yu
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Christopher J. Forlenza
Phone: 212-639-7592
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oakland, California 94611
Principal Investigator: Laura A. Campbell
Phone: 877-642-4691
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Oakland, CA
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8200 Dodge St
Omaha, Nebraska 68114
(402) 955-5400
Principal Investigator: Minnie Abromowitch
Children's Hospital and Medical Center of Omaha Children's Hospital & Medical Center has a rich...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Minnie Abromowitch
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Principal Investigator: Scott M. Bradfield
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Orlando, Florida 32806
Principal Investigator: Don E. Eslin
Phone: 321-843-2584
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2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 276-6500
Principal Investigator: Janice F. Olson
Phone: 503-413-8199
Legacy Emanuel Children's Hospital For generations our children's hospital has provided outstanding care for kids...
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Portland, OR
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Rochester, Minnesota 55905
Principal Investigator: Carola A. Arndt
Phone: 855-776-0015
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Robert J. Hayashi
Phone: 800-600-3606
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, Missouri 63141
Principal Investigator: Bethany G. Sleckman
Phone: 314-251-6770
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San Antonio, Texas 78207
Principal Investigator: Timothy C. Griffin
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San Francisco, California 94158
Principal Investigator: Robert E. Goldsby
Phone: 877-827-3222
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San Juan, 00912
Principal Investigator: Luis A. Clavell
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Douglas S. Hawkins
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
Principal Investigator: Kayelyn J. Wagner
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls Sanford
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Principal Investigator: Judy L. Felgenhauer
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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Syracuse, New York 13214
Principal Investigator: Philip M. Monteleone
Phone: 315-464-5476
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Principal Investigator: Melissa A. Forouhar
Phone: 253-968-0129
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Tampa, Florida 33607
Principal Investigator: Mark J. Mogul
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
Principal Investigator: Jamie L. Dargart
Phone: 419-824-1842
The Toledo Hospital/Toledo Children's Hospital ProMedica's Mission is to improve your health and well-being. And...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Jeffrey S. Dome
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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