Neuroblastoma is a childhood cancer of the adrenal gland or the peripheral nervous system. In many cases, the cancer has already spread through the body by the time it is discovered. Treatment with chemotherapy (anti-cancer) drugs is needed to control the cancer. Standard treatment includes chemotherapy, radiation therapy, and surgery.

This research study will use the combination of irinotecan and gefitinib (ZD1839), in addition to other commonly used drugs to treat neuroblastoma. After the initial treatment with these two drugs, the study will also determine if it is possible to remove the primary tumor in most patients after these two courses of chemotherapy. The goal is to learn the good and bad effects of treating patients with the drug combination. Researchers will also evaluate the effects this drug combination has on the instances of fever, hospitalization, antibiotics use, and blood transfusions. The researchers are also interested in determining the response of the tumor to the drug combination and the survival of the patient after treatment. The effects of the drug on the body and the way they act within the body will also be studied (pharmacokinetics).

The study will have five parts or phases. In the first part the combination of irinotecan and gefitinib will be studied. After that, patients who have responded well will have surgery to remove the tumor. This will be followed by a third part which includes about nine months of treatment with cisplatin, adriamycin, etoposide, cyclophosphamide, and topotecan. The fourth part will be intensification with melphalan, etoposide and carboplatin and blood stem cell rescue. During this part radiation will also be given to sites of disease. Finally monthly treatments with oral retinoic acid alternating with oral topotecan will be continued for a total of 16 months of maintenance. It is anticipated to take about 2 years to complete this entire treatment plan.

Condition	Intervention	Phase
Neoplasms Neuroblastoma	Drug: ZD1839 (gefitinib), Irinotecan, Loperamide hydrochloride  Procedure: Surgery, Radiation therapy, Stem cell transplant	Phase II

Further Study Details: 

Primary Outcomes: To learn the effects (good and bad) of treating patients with the combination of irinotecan and gefitinib (ZD1839); To study the tumors response after treatment with the combination of irinotecan and gefitinib (ZD1839); To learn if the combination of irinotecan and gefitinib will result in fewer instances of fever, hospitalizations, antibiotics use and blood transfusions than the standard treatment; To study the tumors response, and the patients survival, after treatment with the combination of irinotecan and gefitinib (ZD1839), and other commonly used drugs to treat neuroblastoma; To learn how the body uses the drugs and how they act on the body; To learn how FDG PET scans can be used to determine the response of neuroblastoma to treatment
Expected Total Enrollment:  35

Ages Eligible for Study:  1 Year   -   18 Years,  Genders Eligible for Study:  Both

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

Exclusion Criteria:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00135135

Wayne L Furman, MD      1-866-278-5833    info@stjude.org

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting

Study chairs or principal investigators

Wayne L Furman, MD,  Principal Investigator,  St. Jude Children''''s Research Hospital   

Study ID Numbers:  NB2005; AstraZeneca IRUSIERS0389
Last Updated:  August 24, 2005
Record first received:  August 24, 2005
ClinicalTrials.gov Identifier:  NCT00135135
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30