Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospitals, Leicester
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030719
First received: February 14, 2002
Last updated: December 6, 2011
Last verified: August 2010
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Purpose
RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.
PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: filgrastim Biological: monoclonal antibody Ch14.18 Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: isotretinoin Drug: melphalan Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | High Risk Neuroblastoma Study 1 Of Siop-Europe |
Resource links provided by NLM:
Genetics Home Reference related topics:
neuroblastoma
Drug Information available for:
Cyclophosphamide
Busulfan
Melphalan
Vincristine sulfate
Melphalan hydrochloride
Isotretinoin
Etoposide
Carboplatin
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival at 3 years [ Designated as safety issue: No ]
- Mean number of febrile events during induction [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate assessed by the International Neuroblastoma Response Criteria after 4 and 8 induction chemotherapy courses [ Designated as safety issue: No ]
- Event-free survival at 5 years [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Biological factors (i.e., MycNM amplification, 1p deletion, ploidy, 17 q+, CD44, and Trk-A) [ Designated as safety issue: No ]
- Serum concentrations of lactic dehydrogenase, ferritin, neurone specific enolase [ Designated as safety issue: No ]
- Urinary catecholamines at diagnosis [ Designated as safety issue: No ]
| Estimated Enrollment: | 175 |
| Study Start Date: | December 2001 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma according to International Neuroblastoma Staging System
- Stage 2 or 3 with MycN amplification
- Stage 4
- Tumor material available for determination of biological prognostic factors
PATIENT CHARACTERISTICS:
Age:
- 1 to 20 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 3 times normal
- ALT less than 3 times normal
Renal:
- Creatinine less than 1.5 mg/mL
- Creatinine clearance and/or glomerular filtration rate at least 60 mL/min
Cardiovascular:
- Shortening fraction at least 28% OR
- Ejection fraction at least 55%
- No clinical congestive heart failure
Pulmonary:
- Chest x-ray normal
- Oxygen saturation normal
Other:
- HIV negative
- No Brock grade 2 or greater
- No uncontrolled infections requiring IV antivirals, antibiotics, or antifungals
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 1 prior chemotherapy regimen for localized unresectable disease
- No concurrent anthracyclines
- No other concurrent chemotherapy
Endocrine:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent investigational therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030719
Show 32 Study Locations
Show 32 Study LocationsSponsors and Collaborators
University Hospitals, Leicester
Investigators
| Study Chair: | Ruth Ladenstein, MD | St. Anna Kinderkrebsforschung |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00030719 History of Changes |
| Other Study ID Numbers: | CDR0000069191, SIOP-EUROPE-HR-NBL-1, ESIOP, EU-20148 |
| Study First Received: | February 14, 2002 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
regional neuroblastoma disseminated 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 Antibodies Immunoglobulins Antibodies, Monoclonal Busulfan Cyclophosphamide |
Melphalan Lenograstim Etoposide Vincristine Carboplatin Isotretinoin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013