Combination Chemotherapy 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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified |
| Study Start Date: | July 1999 |
OBJECTIVES:
- Confirm that the outcome for infants with newly diagnosed stage IV or IVS neuroblastoma without MYCN amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide, doxorubicin, and vincristine.
- 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 are stratified according to age (under 1 month vs over 1 month).
Infants less than 1 month of age are further stratified according to Philadelphia score (less than 1 vs at least 1). Infants over 1 month of age are also further stratified according to Philadelphia score (less than 2 vs at least 2).
Infants under 1 month of age with Philadelphia score of less than 1 and infants over 1 month of age with Philadelphia score of less than 2 undergo observation only. Infants under 1 month of age with Philadelphia score of at least 1 and infants over 1 month of age with Philadelphia score of at least 2 receive VP-CARBO chemotherapy.
- VP-CARBO chemotherapy: Patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients with no response receive CADO chemotherapy.
- CADO chemotherapy: Patients receive 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 a maximum of 4 courses.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 130 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 or IVS neuroblastoma or ganglioneuroblastoma
Metastases confined to marrow, skin, nodes, or liver
- No metastases to bone (radiologic bone lesions in skeleton), CNS, pleura, or lung
- 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 | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Study Chair: | Mary P. Gerrard, MBChB, FRCP, FRCPCH | Children's Hospital - Sheffield |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025610 History of Changes |
| Other Study ID Numbers: | CDR0000068979, EURO-INF-NB-STUDY-1999-99.2, EU-20125B |
| Study First Received: | October 11, 2001 |
| Last Updated: | July 4, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
disseminated neuroblastoma stage 4S 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 22, 2013