Children's Hospital of Alabama |
Birmingham, Alabama, United States, 35233 |
Contact: Site Public Contact 205-638-9285 oncologyresearch@peds.uab.edu |
Principal Investigator: Elizabeth D. Alva |
Providence Alaska Medical Center |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Brenda J. Wittman |
Banner Children's at Desert |
Mesa, Arizona, United States, 85202 |
Contact: Site Public Contact 480-412-3100 |
Principal Investigator: Joseph C. Torkildson |
Phoenix Childrens Hospital |
Phoenix, Arizona, United States, 85016 |
Contact: Site Public Contact 602-546-0920 |
Principal Investigator: Jessica Boklan |
Banner University Medical Center - Tucson |
Tucson, Arizona, United States, 85719 |
Contact: Site Public Contact aselegue@email.arizona.edu |
Principal Investigator: Holly E. Pariury |
Arkansas Children's Hospital |
Little Rock, Arkansas, United States, 72202-3591 |
Contact: Site Public Contact 501-364-7373 |
Principal Investigator: David L. Becton |
Kaiser Permanente Downey Medical Center |
Downey, California, United States, 90242 |
Contact: Site Public Contact 626-564-3455 |
Principal Investigator: Robert M. Cooper |
City of Hope Comprehensive Cancer Center |
Duarte, California, United States, 91010 |
Contact: Site Public Contact 800-826-4673 becomingapatient@coh.org |
Principal Investigator: Anna B. Pawlowska |
Loma Linda University Medical Center |
Loma Linda, California, United States, 92354 |
Contact: Site Public Contact 909-558-4050 |
Principal Investigator: Albert Kheradpour |
Miller Children's and Women's Hospital Long Beach |
Long Beach, California, United States, 90806 |
Contact: Site Public Contact 562-933-5600 |
Principal Investigator: Jacqueline N. Casillas |
Children's Hospital Los Angeles |
Los Angeles, California, United States, 90027 |
Contact: Site Public Contact 323-361-4110 |
Principal Investigator: Fariba Navid |
Mattel Children's Hospital UCLA |
Los Angeles, California, United States, 90095 |
Contact: Site Public Contact 310-825-6708 |
Principal Investigator: William A. May |
Valley Children's Hospital |
Madera, California, United States, 93636 |
Contact: Site Public Contact 559-353-3000 Research@valleychildrens.org |
Principal Investigator: Karen S. Fernandez |
UCSF Benioff Children's Hospital Oakland |
Oakland, California, United States, 94609 |
Contact: Site Public Contact 510-428-3324 Carla.Golden@ucsf.edu |
Principal Investigator: Carla B. Golden |
Kaiser Permanente-Oakland |
Oakland, California, United States, 94611 |
Contact: Site Public Contact 877-642-4691 Kpoct@kp.org |
Principal Investigator: Laura A. Campbell |
Lucile Packard Children's Hospital Stanford University |
Palo Alto, California, United States, 94304 |
Contact: Site Public Contact 800-694-0012 ccto-office@stanford.edu |
Principal Investigator: Jay Michael S. Balagtas |
UCSF Medical Center-Mission Bay |
San Francisco, California, United States, 94158 |
Contact: Site Public Contact 877-827-3222 |
Principal Investigator: Arun A. Rangaswami |
Children's Hospital Colorado |
Aurora, Colorado, United States, 80045 |
Contact: Site Public Contact 303-764-5056 josh.b.gordon@nsmtp.kp.org |
Principal Investigator: Margaret E. Macy |
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center |
Denver, Colorado, United States, 80218 |
Contact: Site Public Contact 303-839-6000 |
Principal Investigator: Jennifer J. Clark |
Alfred I duPont Hospital for Children |
Wilmington, Delaware, United States, 19803 |
Contact: Site Public Contact 302-651-6884 dperry@nemours.org |
Principal Investigator: Scott M. Bradfield |
MedStar Georgetown University Hospital |
Washington, District of Columbia, United States, 20007 |
Contact: Site Public Contact 202-444-2223 |
Principal Investigator: Jeffrey A. Toretsky |
Children's National Medical Center |
Washington, District of Columbia, United States, 20010 |
Contact: Site Public Contact 202-884-2549 |
Principal Investigator: Jeffrey S. Dome |
Broward Health Medical Center |
Fort Lauderdale, Florida, United States, 33316 |
Contact: Site Public Contact 954-355-5346 |
Principal Investigator: Hector M. Rodriguez-Cortes |
University of Florida Health Science Center - Gainesville |
Gainesville, Florida, United States, 32610 |
Contact: Site Public Contact 352-273-8010 cancer-center@ufl.edu |
Principal Investigator: William B. Slayton |
Nemours Children's Clinic-Jacksonville |
Jacksonville, Florida, United States, 32207 |
Contact: Site Public Contact 904-697-3529 |
Principal Investigator: Scott M. Bradfield |
University of Miami Miller School of Medicine-Sylvester Cancer Center |
Miami, Florida, United States, 33136 |
Contact: Site Public Contact 305-243-2647 |
Principal Investigator: Julio C. Barredo |
Nicklaus Children's Hospital |
Miami, Florida, United States, 33155 |
Contact: Site Public Contact 888-624-2778 |
Principal Investigator: Enrique A. Escalon |
AdventHealth Orlando |
Orlando, Florida, United States, 32803 |
Contact: Site Public Contact 407-303-2090 FH.Cancer.Research@flhosp.org |
Principal Investigator: Fouad M. Hajjar |
Arnold Palmer Hospital for Children |
Orlando, Florida, United States, 32806 |
Contact: Site Public Contact 321-841-2008 melissa.leffin@orlandohealth.com |
Principal Investigator: Amy A. Smith |
Nemours Children's Hospital |
Orlando, Florida, United States, 32827 |
Contact: Site Public Contact 407-650-7715 |
Principal Investigator: Scott M. Bradfield |
Johns Hopkins All Children's Hospital |
Saint Petersburg, Florida, United States, 33701 |
Contact: Site Public Contact 727-767-4784 Ashley.Repp@jhmi.edu |
Principal Investigator: Stacie L. Stapleton |
Saint Joseph's Hospital/Children's Hospital-Tampa |
Tampa, Florida, United States, 33607 |
Contact: Site Public Contact 813-357-0849 jennifer.manns@baycare.org |
Principal Investigator: Don E. Eslin |
Children's Healthcare of Atlanta - Egleston |
Atlanta, Georgia, United States, 30322 |
Contact: Site Public Contact 404-785-2025 Leann.Schilling@choa.org |
Principal Investigator: William T. Cash |
Kapiolani Medical Center for Women and Children |
Honolulu, Hawaii, United States, 96826 |
Contact: Site Public Contact 808-983-6090 |
Principal Investigator: Wade T. Kyono |
Saint Luke's Cancer Institute - Boise |
Boise, Idaho, United States, 83712 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Eugenia Chang |
University of Chicago Comprehensive Cancer Center |
Chicago, Illinois, United States, 60637 |
Contact: Site Public Contact 773-702-8222 cancerclinicaltrials@bsd.uchicago.edu |
Principal Investigator: Susan L. Cohn |
Saint Jude Midwest Affiliate |
Peoria, Illinois, United States, 61637 |
Contact: Site Public Contact 888-226-4343 |
Principal Investigator: Jaime M. Libes |
Southern Illinois University School of Medicine |
Springfield, Illinois, United States, 62702 |
Riley Hospital for Children |
Indianapolis, Indiana, United States, 46202 |
Contact: Site Public Contact 800-248-1199 |
Principal Investigator: Sandeep Batra |
Blank Children's Hospital |
Des Moines, Iowa, United States, 50309 |
Contact: Site Public Contact 515-241-8912 samantha.mallory@unitypoint.org |
Principal Investigator: Samantha L. Mallory |
University of Iowa/Holden Comprehensive Cancer Center |
Iowa City, Iowa, United States, 52242 |
Contact: Site Public Contact 800-237-1225 |
Principal Investigator: Mariko Sato |
University of Kentucky/Markey Cancer Center |
Lexington, Kentucky, United States, 40536 |
Contact: Site Public Contact 859-257-3379 |
Principal Investigator: James T. Badgett |
Children's Hospital New Orleans |
New Orleans, Louisiana, United States, 70118 |
Contact: Site Public Contact CHResearch@lcmchealth.org |
Principal Investigator: Lolie C. Yu |
Ochsner Medical Center Jefferson |
New Orleans, Louisiana, United States, 70121 |
Contact: Site Public Contact 504-703-8712 Gregory.Johnstone@ochsner.org |
Principal Investigator: Craig Lotterman |
Eastern Maine Medical Center |
Bangor, Maine, United States, 04401 |
Contact: Site Public Contact 207-973-4274 |
Principal Investigator: Nadine P. SantaCruz |
Sinai Hospital of Baltimore |
Baltimore, Maryland, United States, 21215 |
Contact: Site Public Contact 410-601-6120 pridgely@lifebridgehealth.org |
Principal Investigator: Jason M. Fixler |
Johns Hopkins University/Sidney Kimmel Cancer Center |
Baltimore, Maryland, United States, 21287 |
Contact: Site Public Contact 410-955-8804 jhcccro@jhmi.edu |
Principal Investigator: Kenneth J. Cohen |
Massachusetts General Hospital Cancer Center |
Boston, Massachusetts, United States, 02114 |
Contact: Site Public Contact 877-726-5130 |
Principal Investigator: Katherine A. Janeway |
Dana-Farber Cancer Institute |
Boston, Massachusetts, United States, 02215 |
Contact: Site Public Contact 877-442-3324 |
Principal Investigator: Katherine A. Janeway |
C S Mott Children's Hospital |
Ann Arbor, Michigan, United States, 48109 |
Contact: Site Public Contact 800-865-1125 |
Principal Investigator: Rajen Mody |
Helen DeVos Children's Hospital at Spectrum Health |
Grand Rapids, Michigan, U
May 15, 2018
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May 16, 2018
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June 9, 2021
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June 25, 2018
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June 30, 2025 (Final data collection date for primary outcome measure)
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Objective response rate [ Time Frame: Up to 5 years ] Defined as a patient who achieves a best response of partial response or complete response on the study. Confidence intervals will be constructed using the Wilson score interval method.
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Objective response rate defined as a patient who achieves a best response of partial response or complete response on the study [ Time Frame: Up to 5 years ] Confidence intervals will be constructed using the Wilson score interval method.
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- Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to disease progression or disease recurrence or death from any cause, assessed up to 5 years ]
PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
- Incidence of adverse events [ Time Frame: Up to 5 years ]
Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- Pharmacokinetic (PK) parameters [ Time Frame: Up to 5 years ]
PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
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- Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to disease progression or disease recurrence or death from any cause, assessed up to 5 years ]
PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
- Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 5 years ]
- Pharmacokinetic (PK) parameters [ Time Frame: Up to 5 years ]
PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
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Changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid [ Time Frame: Baseline up to 5 years ] A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
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Same as current
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Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Palbociclib in Patients With Tumors Harboring Activating Alterations in Cell Cycle Genes
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This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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PRIMARY OBJECTIVE:
I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with palbociclib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in cell cycle genes.
SECONDARY OBJECTIVES:
I. To estimate the progression free survival in pediatric patients treated with palbociclib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in alterations in cell cycle genes.
II. To obtain information about the tolerability of palbociclib in children and adolescents with relapsed or refractory cancer.
EXPLORATORY OBJECTIVE:
I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
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Interventional
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Phase 2
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Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
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- Advanced Malignant Solid Neoplasm
- Recurrent Childhood Ependymoma
- Recurrent Ewing Sarcoma
- Recurrent Glioma
- Recurrent Hepatoblastoma
- Recurrent Kidney Wilms Tumor
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Malignant Germ Cell Tumor
- Recurrent Malignant Glioma
- Recurrent Medulloblastoma
- Recurrent Neuroblastoma
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Osteosarcoma
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Recurrent Rhabdoid Tumor
- Recurrent Rhabdomyosarcoma
- Recurrent Soft Tissue Sarcoma
- Refractory Ependymoma
- Refractory Ewing Sarcoma
- Refractory Glioma
- Refractory Hepatoblastoma
- Refractory Langerhans Cell Histiocytosis
- Refractory Malignant Germ Cell Tumor
- Refractory Malignant Glioma
- Refractory Medulloblastoma
- Refractory Neuroblastoma
- Refractory Non-Hodgkin Lymphoma
- Refractory Osteosarcoma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Refractory Rhabdoid Tumor
- Refractory Rhabdomyosarcoma
- Refractory Soft Tissue Sarcoma
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- Other: Laboratory Biomarker Analysis
Correlative studies
- Drug: Palbociclib
Given PO
Other Names:
- 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
- Ibrance
- PD 0332991
- PD 332991
- PD 991
- PD-0332991
- Other: Pharmacological Study
Correlative studies
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Experimental: Treatment (palbociclib)
Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions:
- Other: Laboratory Biomarker Analysis
- Drug: Palbociclib
- Other: Pharmacological Study
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Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.
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Recruiting
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49
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Same as current
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June 30, 2025
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June 30, 2025 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
-
Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621I based on the presence of an actionable mutation
- In addition to the actionable mutations, positive Rb expression by immunohistochemistry is required for study enrollment
- Patients must have a body surface area >= 0.87 m^2 at enrollment
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Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have MIBG+ 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
- 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
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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
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Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
- >= 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 counts [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)
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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.)
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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 morrow (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, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
- Patients must not have received prior exposure to palbociclib, ribociclib, abemaciclib or any other CDK4/6 inhibitors
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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 (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
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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 (mg/dL): male 0.6; female 0.6
- Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
- Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1
- Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
- Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
- Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)
- Serum albumin >= 2 g/dL
- Patients must be able to swallow intact capsules
- 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 due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment; females study participants of child-bearing potential and their partners, should agree to use highly effective forms of contraception for at least 3 weeks after the last dose of palbociclib; male study participants should avoid fathering a child, donating sperm, and should agree to use highly effective forms of contraception for at least 3 months after the last dose of palbociclib
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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
- CYP3A4 agents: Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
- Patients who have an uncontrolled infection are not eligible
- Patients who have received a prior solid organ transplantation are not eligible
- 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
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Sexes Eligible for Study: |
All |
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12 Months to 21 Years (Child, Adult)
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No
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Puerto Rico, United States
|
|
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NCT03526250
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NCI-2018-00863 NCI-2018-00863 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) APEC1621I ( Other Identifier: Children's Oncology Group ) APEC1621I ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract )
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
|
Not Provided
|
National Cancer Institute (NCI)
|
National Cancer Institute (NCI)
|
Not Provided
|
Principal Investigator: |
Rajen Mody |
Children's Oncology Group |
|
National Cancer Institute (NCI)
|
January 2021
|
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