Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
Study Details
Study Description
Brief Summary
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 2 Arm A Palbociclib in combination with irinotecan and temozolomide. |
Drug: Palbociclib
Phase 1: Administered (oral) at 55 mg/m2, 75 mg/m2, or 40 mg/m2, or 95 mg/m2 or 115 mg/m2 on days 1-14 of a 21-day cycle Phase 2 : Administered (oral) at 75 mg/m2 on days 1-14 of a 21-day cycle
Other Names:
Drug: Temozolomide
Phase 1 and Phase 2: Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle
Other Names:
Drug: Irinotecan
Phase 1 and Phase 2: Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Other Names:
|
| Experimental: Phase 1 Palbociclib in combination with temozolomide and irinotecan and/or with topotecan and cyclophosphamide. |
Drug: Palbociclib
Phase 1: Administered (oral) at 55 mg/m2, 75 mg/m2, or 40 mg/m2, or 95 mg/m2 or 115 mg/m2 on days 1-14 of a 21-day cycle Phase 2 : Administered (oral) at 75 mg/m2 on days 1-14 of a 21-day cycle
Other Names:
Drug: Temozolomide
Phase 1 and Phase 2: Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle
Other Names:
Drug: Irinotecan
Phase 1 and Phase 2: Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Other Names:
Drug: Topotecan
Phase 1 only : Administered at 0.75 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Other Names:
Drug: Cyclophosphamide
Phase 1 only: Administered at 250 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Other Names:
|
| Active Comparator: Phase 2 Arm B Irinotecan and temozolomide alone. |
Drug: Temozolomide
Phase 1 and Phase 2: Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle
Other Names:
Drug: Irinotecan
Phase 1 and Phase 2: Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Phase 2 open-label, randomized: Event-free survival (EFS) based on Investigator assessment. [Baseline to Month 24.]
EFS is defined as the time from randomization until first event (ie, progression, recurrence following response, second malignancy or death without progression or recurrence).
- Phase 1: First Cycle Dose-Limiting Toxicities (DLT) [First cycle (cycle length is approximately 21 days)]
For Dose Escalation/Determination Part: DLT defined as any of the following events occurring during the first treatment cycle and considered at least possibly-related to study medication:Grade 4 neutropenia lasting greater than 7 days;Grade 4 thrombocytopenia lasting greater than 7 days or need for platelet transfusion for a platelet count of < 20,000 per cubic millimeters twice within a 7-day period;greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia;Grade 3 or greater non-hematologic toxicities despite optimal treatment;any Grade 2 or greater non-hematologic toxicity requiring discontinuation or interruption of palbociclib for 7 or more consecutive days during the first cycle or any grade non-hematologic toxicity that delays the start of Cycle 2 by more than 14 days;clinically significant non-hematologic laboratory test abnormality Grade 3 or greater not resolving to Grade 1 or baseline within 7 days.
- Phase 1: Dose Expansion Parts: Frequency of adverse events [At least 28 days after last dose]
For Dose Expansion and Tumor-Specific Expansion Parts: Adverse events to be reported during treatment and for at least 28 days after last dose.
- Phase 1: Dose Expansion Parts: Percentage of Participants With Complete Response or Partial Response [Through the end of treatment (up to at least 28 days after last dose)]
For Dose Expansion and Tumor-Specific Expansion Parts: patients with confirmed Complete Response or Partial Response per Response Evaluation Criteria in Solid Tumors (RECIST, v.1.1) or modified Response Assessment in Neuro-Oncology (RANO) for central nervous system malignancies, or International Neuroblastoma Response Criteria (INRC) for neuroblastoma, during study treatment, assessed approximately every 2 to 4 cycles (each cycle is approximately 21 days).
Secondary Outcome Measures
- Phase 1 and Phase 2: Frequency of adverse events [At least 28 days after last dose]
Adverse events to be reported during treatment and for at least 28 days after last dose.
- Phase 1 and Phase 2: Percentage of participants with laboratory abnormalities [At least 28 days after last dose]
Magnesium, Calcium, Creatinine, Albumin, Alanine aminotransferase, Aspartate aminotransferase, Glucose, Phosphorus, Total Bilirubin, Blood urea nitrogen, Alkaline phosphatase, Sodium, Potassium, Chloride, Platelet Count, White Blood Cell Count (differential), hemoglobin, INR or prothrombin Time, HbA1c
- Phase 1 and Phase 2: Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings [At least 28 days after last dose]
Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.
- Phase 1 and Phase 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs [At least 28 days after last dose]
systolic and diastolic blood pressure, pulse
- Phase 2 open-label, randomized: Event-free survival (EFS) assessed by an independent review committee. [Baseline to Month 24.]
EFS is defined as the time from randomization until first event (ie, progression, recurrence following response, second malignancy or death without progression or recurrence).
- Phase 1 and Phase 2: Percentage of Participants With Complete Response or Partial Response [Through the end of treatment (up to at least 28 days after last dose)]
Patients with confirmed Complete Response or Partial Response per Response Evaluation Criteria in Solid Tumors (RECIST, v.1.1) or modified Response Assessment in Neuro-Oncology (RANO) for central nervous system malignancies, or International Neuroblastoma Response Criteria (INRC) for neuroblastoma, during study treatment, assessed approximately every 2 to 4 cycles (each cycle is approximately 21 days).
- Phase 1 and Phase 2: Duration of response (DoR) for Participants Who Achieved Complete Response or Partial Response [Up to 2 years]
DoR defined as time from date of first response (Complete Response or Partial Response) in responders to date of progression or death
- Phase 1 and Phase 2: Progression Free Survival (PFS) [Up to 2 years]
PFS defined as time from date of enrollment to earliest date of the death or progressive disease
- Phase 1 and Phase 2: Overall Survival (OS) [Up to 2 years]
OS defined as the time from enrollment to date of death due to any cause.
- Phase 2 : comparison of PET-CT response assessment to objective response on CT/MRI. [up to completion of Cycle 4 ( 12 weeks of therapy)]
PET-CT response assessment will be compared to objective response on MRI/CT, as data permit.
- Phase 2: the impact of the combination of palbociclib with TMZ and IRN treatment on the quality of life (QoL) of patients with refractory or recurrent EWS. [Up to Cycle 5 (completion of 12 weeks of treatment)]
Results of QoL reported by patient at baseline and after 2 and 4 cycles using age-appropriate PROMIS tools will be summarized for both treatment arms, as data permit. Days of hospitalization will be compared in both treatment arms.
- Phase 1 and Phase 2:Palbociclib Pharmacokinetics, Maximum observed plasma concentration during a dosing interval at steady state (Css, max) [PK sampling at time points during Cycle 1 (day 2, 5, 6, 14) and Cycle 2 (day 5 and 14). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Palbociclib Pharmacokinetics, Maximum plasma concentration time (Tmax) [PK sampling at time points during Cycle 1 (day 2, 5, 6, 14) and Cycle 2 (day 5 and 14). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Palbociclib Pharmacokinetics, Area under the concentration-time curve during a dosing interval at steady state (AUCss,t) [PK sampling at time points during Cycle 1 (day 2,5, 6,14) and Cycle 2 (day 5 and 14). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Palbociclib Pharmacokinetics, Measured concentration at the end of a dosing interval at steady state (taken directly before next administration) (Css,trough) [PK sampling at time points during Cycle 1 (day 2, 5, 6, 14) and Cycle 2 (day 5 and 14). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Palbociclib Pharmacokinetics, Oral plasma clearance (CL/F) [PK sampling at time points during Cycle 1 (day 2, 5, 6, 14) and Cycle 2 (day 5 and 14). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Temozolomide Pharmacokinetics, Maximum observed plasma concentration during a dosing interval at steady state (Css, max) [PK sampling at time points during Cycle 1 (day 5) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Temozolomide Pharmacokinetics, Maximum plasma concentration time (Tmax) [PK sampling at time points during Cycle 1 (day 5) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Temozolomide Pharmacokinetics, Area under the concentration-time curve during a dosing interval at steady state (AUCss,t) [PK sampling at time points during Cycle 1 (day 5) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Temozolomide Pharmacokinetics, Measured concentration at the end of a dosing interval at steady state (taken directly before next administration) (Css,trough) [PK sampling at time points during Cycle 1 (day 5) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Temozolomide Pharmacokinetics, Oral plasma clearance (CL/F) [PK sampling at time points during Cycle 1 (day 5) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Irinotecan (and active metabolites) Pharmacokinetics, Maximum observed plasma concentration during a dosing interval at steady state (Css, max) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Irinotecan (and active metabolites) Pharmacokinetics, Maximum plasma concentration time (Tmax) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Irinotecan (and active metabolites) Pharmacokinetics, Area under the concentration-time curve during a dosing interval at steady state (AUCss,t) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Irinotecan (and active metabolites), Measured concentration at the end of a dosing interval at steady state (taken directly before next administration) (Css,trough) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1 and Phase 2: Irinotecan (and active metabolites) Pharmacokinetics, Oral plasma clearance (CL/F) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Topotecan (and active metabolites) Pharmacokinetics, Oral plasma clearance (CL/F) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Topotecan (and active metabolites), Measured concentration at the end of a dosing interval at steady state (taken directly before next administration) (Css,trough) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Topotecan (and active metabolites) Pharmacokinetics, Area under the concentration-time curve during a dosing interval at steady state (AUCss,t) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Topotecan (and active metabolites) Pharmacokinetics, Maximum plasma concentration time (Tmax) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Topotecan (and active metabolites) Pharmacokinetics, Maximum observed plasma concentration during a dosing interval at steady state (Css, max) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Cyclophosphamide Pharmacokinetics, Oral plasma clearance (CL/F) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Cyclophosphamide Pharmacokinetics, Maximum observed plasma concentration during a dosing interval at steady state (Css, max) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Cyclophosphamide Pharmacokinetics, Maximum plasma concentration time (Tmax) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Cyclophosphamide Pharmacokinetics, Area under the concentration-time curve during a dosing interval at steady state (AUCss,t) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
- Phase 1: Cyclophosphamide Pharmacokinetics, Measured concentration at the end of a dosing interval at steady state (taken directly before next administration) (Css,trough) [PK sampling at time points during Cycle 1 (day 2, 5 and 6) and Cycle 2 (day 5). Each cycle is 21 days.]
Multiple Dose (assuming steady state is achieved), as data permit
Eligibility Criteria
Criteria
Inclusion:
- Histologically confirmed relapsed or refractory solid tumor as follows:
-
For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.
-
For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.
-
For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement. Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging.
-
Age ≥2 and <21 years at the time of study entry.
-
Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age.
-
Adequate bone marrow function.
-
Absolute neutrophil count ≥1000/mm3;
-
Platelet count ≥100,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry);
-
Hemoglobin ≥8.5 g/dL (transfusion allowed).
-
Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
-
Adequate liver function, including:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver;
- Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.
-
Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1.1 or modified RANO criteria for CNS disease or INRC for neuroblastoma. Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component).
-
Recovered to CTCAE Grade ≤1, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia.
-
Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit.
Exclusion:
-
Phase 1 and tumor specific cohorts: For palbociclib with IRN and TMZ combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing regimen that includes TMZ. Patients who have received the combination of IRN and TMZ and did not progress while on these medications are eligible. For patients enrolling in the palbociclib with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with a TOPO-containing regimen that includes CTX. Patients who have received the combination of TOPO and CTX and did not progress while on these medications are eligible. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing or TMZ-containing regimen. Patients who have received IRN and/or TMZ and did not progress while on these medications are eligible.
-
Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination.
-
Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers. Patients who are receiving strong uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of Cycle 1 Day 1 (C1D1) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5.7.1 for list of products.)
-
Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
-
Prior irradiation to >50% of the bone marrow (see Appendix 9).
-
Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
-
Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
-
For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX.
-
Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days.
-
Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post radiation and 4 weeks post-surgery and are neurologically stable.
-
Hereditary bone marrow failure disorder.
-
QTc >470 msec.
-
History of clinically significant or uncontrolled cardiac disease, including:
-
History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible;
-
Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
-
Diagnosed or suspected congenital or acquired prolonged QT syndrome;
-
Need for medications known to prolong the QT interval;
-
Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval;
-
Left ventricular ejection fraction <50% or shortening fraction <28%.
-
Recent or ongoing clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (eg, gastrectomy).
-
Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
-
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 3 | MemorialCare Health System - Long Beach Medical Center | Long Beach | California | United States | 90806 |
| 4 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 5 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609 |
| 6 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 7 | Lucile Packard Children's Hospital | Palo Alto | California | United States | 94304 |
| 8 | UCSF Medical Center | San Francisco | California | United States | 94158 |
| 9 | University of California San Francisco, | San Francisco | California | United States | 94158 |
| 10 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 11 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 12 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 13 | UF Health Shands Hospital | Gainesville | Florida | United States | 32610 |
| 14 | University of Florida College of Medicine | Gainesville | Florida | United States | 32610 |
| 15 | Arnold Palmer Hospital for Children | Orlando | Florida | United States | 32806 |
| 16 | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 17 | Johns Hopkins All Children's Outpatient Care Center | Saint Petersburg | Florida | United States | 33701 |
| 18 | Johns Hopkins All Children's Hospital | Tampa | Florida | United States | 33612 |
| 19 | Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | United States | 30322 |
| 20 | Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | United States | 30342 |
| 21 | Children's Healthcare of Atlanta, Medical Office Building | Atlanta | Georgia | United States | 30342 |
| 22 | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | United States | 60611 |
| 23 | University of Illinois College of Medicine at Peoria | Peoria | Illinois | United States | 61605 |
| 24 | Indiana University | Indianapolis | Indiana | United States | 46202-5225 |
| 25 | Norton Children's Hospital | Louisville | Kentucky | United States | 40202 |
| 26 | Novak Center for Children's Health | Louisville | Kentucky | United States | 40202 |
| 27 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
| 28 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 29 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
| 30 | University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | United States | 55454 |
| 31 | University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | United States | 55455 |
| 32 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 33 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 34 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 35 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 36 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 37 | Children's Hospital & Medical Center | Omaha | Nebraska | United States | 68114 |
| 38 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 39 | Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 40 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 41 | Cohen Children's Medical Center | New Hyde Park | New York | United States | 11040 |
| 42 | Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital | New York | New York | United States | 10032 |
| 43 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 44 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 45 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 46 | Cincinnati Children's Liberty Campus | Liberty Township | Ohio | United States | 45044 |
| 47 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 48 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 49 | Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 50 | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 51 | Buerger Center for Advanced Pediatric Care | Philadelphia | Pennsylvania | United States | 19104 |
| 52 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 53 | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15224 |
| 54 | Children's Blood and Cancer Center | Austin | Texas | United States | 78723 |
| 55 | Dell Children's Medical Center | Austin | Texas | United States | 78723 |
| 56 | Children's Medical Center Dallas | Dallas | Texas | United States | 75235 |
| 57 | Cook Children's Medical Center | Fort Worth | Texas | United States | 76104 |
| 58 | Cook Children's H/O Infusion Center | Grapevine | Texas | United States | 76051 |
| 59 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
| 60 | Children's Medical Center Plano | Plano | Texas | United States | 75024 |
| 61 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
| 62 | Children's Hospital of Richmond at VCU | Richmond | Virginia | United States | 23298 |
| 63 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 64 | Children's Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 65 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 66 | Alberta Children's Hospital | Calgary | Alberta | Canada | T3B 6A8 |
| 67 | Stollery Children's Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 68 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 69 | CHU Sainte-Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 70 | Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház | Miskolc | Borsod-abaúj-zemplén | Hungary | 3526 |
| 71 | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs | Hungary | 7623 | |
| 72 | All India Institute of Medical Sciences | New Delhi | Delhi | India | 110029 |
| 73 | Rajiv Gandhi Cancer Institute And Research Centre | New Delhi | Delhi | India | 110085 |
| 74 | Artemis hospital | Gurugram | Haryana | India | 122001 |
| 75 | National Cancer Center | Goyang-si | Kyǒnggi-do | Korea, Republic of | 10408 |
| 76 | Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [seoul] | Korea, Republic of | 03080 |
| 77 | Asan Medical Center | Seoul | Seoul-teukbyeolsi [seoul] | Korea, Republic of | 05505 |
| 78 | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [seoul] | Korea, Republic of | 06351 |
| 79 | Instytut Matki i Dziecka | Warsaw | Mazowieckie | Poland | 01-211 |
| 80 | Detska Fakultna nemocnica s poliklinikou Banska Bystrica | Banska Bystrica | Slovakia | 974 09 | |
| 81 | Narodny ustav detskych chorob | Bratislava | Slovakia | 83340 | |
| 82 | Astrid Lindgrens Barnsjukhus | Stockholm | Sweden | 17165 | |
| 83 | Ege Universitesi Hastanesi | İzmir | İ̇zmir | Turkey | 35100 |
| 84 | Hacettepe Universite Hastaneleri | Ankara | Turkey | 06100 |
Sponsors and Collaborators
- Pfizer
- Children's Oncology Group (COG)
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A5481092
- 2021-003444-25