Overview

Therapy for Children With Neuroblastoma

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborators:
AstraZeneca
National Institutes of Health (NIH)
Treatments:
Carboplatin
Doxorubicin
Etoposide
Gefitinib
Irinotecan
Isotretinoin
Melphalan
Topotecan
Tretinoin
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