Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00002803|
Recruitment Status : Completed
First Posted : May 12, 2004
Last Update Posted : December 19, 2013
RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells.
PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: vincristine sulfate Procedure: conventional surgery||Phase 2|
OBJECTIVES: I. Determine the incidence of spontaneous regression of localized neuroblastoma in infants. II. Determine how many infants with neuroblastoma do not need chemotherapy. III. Evaluate the time course of regression by radiologic criteria and catecholamine metabolites. IV. Determine the reliability of risk estimation by molecular characteristics (N-myc amplification, CD44, del 1p) compared to clinical criteria. V. Evaluate whether reduced therapeutic toxicity results in a decrease in treatment-related deaths. VI. Correlate cytostatic drug levels with chemotherapy side effects.
OUTLINE: All patients undergo resection of the primary tumor and N-myc determination within 6 months of age, unless critically ill, then are treated according to risk. Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90. Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin, vincristine, and cyclophosphamide over 7 days. Patients with no amplification of N-myc are observed for 6 months (until between 12 and 18 months of age). Patients with minimal residual disease (less than 10% or diameter no greater than 2-5 mm) continue observation, while those with residual disease but no disease progression undergo repeat biopsy. Patients whose biopsy indicates tumor regression also continue observation. All other patients, including those with disease progression, are treated per protocol GER-NB90.
PROJECTED ACCRUAL: 36-44 patients per year will be accrued (22-27 patients with stages 1-3, 8-10 patients with stage 4S, and 6-7 patients with stage 4 neuroblastoma).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Official Title:||COOPERATIVE MULTICENTER TRIAL FOR THE TREATMENT OF INFANTS WITH NEUROBLASTOMA|
|Study Start Date :||July 1995|
|Study Completion Date :||February 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002803
|University of Cologne|
|Frechen, Germany, DOH-5-0226|
|Study Chair:||Frank Berthold, MD||Children's Hospital Medical Center, Cincinnati|