Therapy for Children With Neuroblastoma

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00135135
First received: August 24, 2005
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Drug: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
Procedure: Radiation therapy, Surgery, Peripheral Stem cell transplant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neuroblastoma Protocol 2005: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: Within 30 days of completion of window therapy. ]

Enrollment: 23
Study Start Date: August 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Gefitinib, Irinotecan, Cycophosphamide, Doxorubicin, Etoposide, Cisplatin, Topotecan, Carboplatin, Melphalan, 13-cis retinoic acid
See Detailed Description.
Procedure: Radiation therapy, Surgery, Peripheral Stem cell transplant
See Detailed Description.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135135

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
AstraZeneca
Investigators
Principal Investigator: Wayne L Furman, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Wayne L. Furman M.D./Prinicipal Investigator, St.Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00135135     History of Changes
Other Study ID Numbers: NB2005, AstraZeneca IRUSIERS0389
Study First Received: August 24, 2005
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Cancer
Childhood Tumor
Neoplasms

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Gefitinib
Cisplatin
Doxorubicin
Etoposide
Melphalan
Tretinoin
Carboplatin
Topotecan
Isotretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Dermatologic Agents
Myeloablative Agonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 28, 2014