Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

May 24, 2019

Primary Completion Date

August 26, 2024

Study Completion Date

October 18, 2025

Conditions
Ewing SarcomaSolid TumorsRhabdoid TumorRhabdomyosarcomaNeuroblastomaMedulloblastomaDiffuse Intrinsic Pontine Glioma
Interventions
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 1 Tumor specific cohort-Neuroblastoma and Phase 2 : Administered (oral) at 75 mg/m2 on days 1-14 of a 21-day cycle

DRUG

Temozolomide

Phase 1 and Phase 2: Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle

DRUG

Irinotecan

Phase 1 and Phase 2: Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle

DRUG

Topotecan

Phase 1 only : Administered at 0.75 mg/m2 (intravenous), on days 1-5 of a 21-day cycle

DRUG

Cyclophosphamide

Phase 1 only: Administered at 250 mg/m2 (intravenous), on days 1-5 of a 21-day cycle

Trial Locations (101)

10032

Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital, New York

10408

National Cancer Center, Goyang-si

10467

Montefiore Medical Center, The Bronx

11040

Cohen Children's Medical Center, New Hyde Park

13385

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone, Marseille

14203

John R. Oishei Childrens Hospital, Buffalo

14263

Roswell Park Cancer Institute, Buffalo

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

17033

Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center, Hershey

19104

Buerger Center for Advanced Pediatric Care, Philadelphia

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Hospital, Washington D.C.

21287

Johns Hopkins University, Baltimore

23219

Children's Hospital of Richmond at VCU, Richmond

23507

Children's Hospital of The King's Daughters, Norfolk

28009

Hospital Infantil Universitario Niño Jesús, Madrid

30322

Children's Healthcare of Atlanta at Egleston, Atlanta

30342

Children's Healthcare of Atlanta at Scottish Rite, Atlanta

Children's Healthcare of Atlanta, Medical Office Building, Atlanta

32610

UF Health Shands Hospital, Gainesville

University of Florida College of Medicine, Gainesville

33076

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux

33612

Johns Hopkins All Children's Hospital, Tampa

33701

Johns Hopkins All Children's Hospital, St. Petersburg

Johns Hopkins All Children's Outpatient Care Center, St. Petersburg

35100

Ege Universitesi Hastanesi, Izmir

35233

University of Alabama at Birmingham/Children's of Alabama, Birmingham

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

Novak Center for Children's Health, Louisville

43205

Nationwide Children's Hospital, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

45044

Cincinnati Children's Liberty Campus, Liberty Township

45122

Universitätsklinikum Essen, Essen

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48109

University of Michigan Health System, Ann Arbor

53226

Children's Wisconsin, Milwaukee

Medical College of Wisconsin, Milwaukee

55454

University of Minnesota Masonic Children's Hospital, Minneapolis

55455

University of Minnesota Medical Center, Fairview, Minneapolis

University of Minnesota/Masonic Cancer Center, Minneapolis

University of Minnesota, Minneapolis

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

64108

Children's Mercy Hospital, Kansas City

69008

Centre Leon Berard, Lyon

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75024

Children's Medical Center Plano, Plano

75235

Children's Medical Center Dallas, Dallas

76051

Cook Children's H/O Infusion Center, Grapevine

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital, Houston

78723

Children's Blood and Cancer Center, Austin

Dell Children's Medical Center, Austin

80045

Children's Hospital Colorado, Aurora

83340

Narodny ustav detskych chorob, Bratislava

84113

Intermountain - Primary Children's Hospital, Salt Lake City

Primary Children's Hospital Outpatient Services, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

90806

MemorialCare Health System - Long Beach Medical Center, Long Beach

92868

Children's Hospital of Orange County, Orange

94158

UCSF Medical Center, San Francisco

University of California San Francisco,, San Francisco

94304

Lucile Packard Children's Hospital, Palo Alto

94609

Children's Hospital and Research Center at Oakland, Oakland

94800

Gustave Roussy, Villejuif

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

110029

All India Institute of Medical Sciences, New Delhi

110085

Rajiv Gandhi Cancer Institute And Research Centre, New Delhi

122001

Artemis hospital, Gurugram

14784400

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos

90410000

Hospital de Clinicas de Porto Alegre, Porto Alegre

08901

Robert Wood Johnson University Hospital, New Brunswick

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

80250-060

Hospital Pequeno Principe / A ssociacao Hospitalar de Protecao a Infancia, Curitiba

Hospital Pequeno Príncipe, Curitiba

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

20230-130

Instituto Nacional de Câncer - INCA, Rio de Janeiro

08270-070

Hospital Santa Marcelina, São Paulo

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 2B7

Stollery Children's Hospital, Edmonton

M5G 1X8

The Hospital for Sick Children, Toronto

H3T 1C5

CHU Sainte-Justine, Montreal

613 00

Detska nemocnice FN Brno, Brno

150 06

Fakultni nemocnice v Motole, Prague

69373 CEDEX 08

Centre Leon Berard, Lyon

01-211

Instytut Matki i Dziecka, Warsaw

974 09

Detska fakultna nemocnica s poliklinikou Banska Bystrica, Banská Bystrica

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

416 50

Sahlgrenska Universitetssjukhuset Östra, Gothenburg

06100

Hacettepe Universite Hastaneleri, Ankara

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

G51 4TF

Royal Hospital for Children, Glasgow

LS1 3EX

Leeds General Infirmary, Leeds

NW1 2PG

University College London Hospital, NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Children's Oncology Group

NETWORK

lead

Pfizer

INDUSTRY