Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified |
| Study Start Date: | July 1999 |
OBJECTIVES:
- Confirm that the management of infants with newly diagnosed stage IV neuroblastoma without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide, doxorubicin, and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation.
- Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
- Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.
OUTLINE: This is a multicenter study.
Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses.
Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy. Patients with metastatic complete response (CR) undergo surgical resection of primary disease.
Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses.
After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection of primary disease. Patients with residual disease receive 2 additional courses of CADO chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study. Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed stage IV neuroblastoma or ganglioneuroblastoma
- Metastases to bone, CNS, or pleura/lung by x-ray or CT scan
- No MYCN amplification (i.e., fewer than 10 copies)
PATIENT CHARACTERISTICS:
Age:
- Under 12 months at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations| Austria | |
| St. Anna Children's Hospital | |
| Vienna, Austria, A-1090 | |
| Belgium | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| France | |
| Centre Hospitalier Regional de Purpan | |
| Toulouse, France, 31026 | |
| Italy | |
| Istituto Giannina Gaslini | |
| Genoa, Italy, 16148 | |
| Norway | |
| Rikshospitalet University Hospital | |
| Oslo, Norway, 0027 | |
| Portugal | |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A. | |
| Lisboa, Portugal, 1099-023 Codex | |
| Spain | |
| Hospital Universitario LA FE | |
| Valencia, Spain, 46009 | |
| Sweden | |
| Ostra Sjukhuset | |
| Gothenburg, Sweden, 41685 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Study Chair: | Bruno De Bernardi, MD | Istituto Giannina Gaslini |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025623 History of Changes |
| Other Study ID Numbers: | CDR0000068980, EURO-INF-NB-STUDY-1999-99.3, EU-20125C |
| Study First Received: | October 11, 2001 |
| Last Updated: | April 23, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
disseminated 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 Doxorubicin Etoposide Vincristine Carboplatin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 21, 2013