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Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002803
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: April 2008
  Purpose

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 Intervention Phase
Neuroblastoma Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: COOPERATIVE MULTICENTER TRIAL FOR THE TREATMENT OF INFANTS WITH NEUROBLASTOMA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 44
Study Start Date: July 1995
Study Completion Date: February 2002
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

  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: NCT00002803

Locations
Germany
University of Cologne
Frechen, Germany, DOH-5-0226
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Study Chair: Frank Berthold, MD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002803     History of Changes
Other Study ID Numbers: CDR0000064903
GER-NB95-S
EU-96003
Study First Received: November 1, 1999
Last Updated: December 18, 2013

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma

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
Cyclophosphamide
Liposomal doxorubicin
Vincristine
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on June 22, 2017