NCT00135135

Brief Summary

This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 3, 2008

Status Verified

June 1, 2008

Enrollment Period

1.8 years

First QC Date

August 24, 2005

Last Update Submit

June 2, 2008

Conditions

Neuroblastoma

Keywords

CancerChildhood TumorNeoplasms

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Within 30 days of completion of window therapy.

Study Arms (1)

1

OTHER
Drug: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acidProcedure: Radiation therapy, Surgery, Peripheral Stem cell transplant

Interventions

Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acidDRUG

See Detailed Description.

1
Radiation therapy, Surgery, Peripheral Stem cell transplantPROCEDURE

See Detailed Description.

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient is less than or equal to 18 years of age
  • Patient is newly diagnosed with high-risk neuroblastoma
  • Patient has adequate kidney and liver function
  • No prior therapy, unless an emergency situation requires local tumor treatment (discuss with PI)

You may not qualify if:

  • Known severe hypersensitivity to ZD1839 or any of the excipients of this product
  • Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
  • Pregnant or breast feeding (women of child-bearing potential).
  • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
  • Children with INSS 4 disease, age \<12 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

NeuroblastomaNeoplasms

Interventions

GefitinibIrinotecanDoxorubicinEtoposideCisplatinTopotecanCarboplatinMelphalanIsotretinoinRadiotherapySurgical Procedures, OperativePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCamptothecinAlkaloidsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesPigments, BiologicalBiological FactorsTherapeuticsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantation

Study Officials

  • Wayne L Furman, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 25, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 3, 2008

Record last verified: 2008-06

Locations

US(1)