Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma - Full Text View

Sponsor:	Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00526318

Purpose

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.

PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.

Condition	Intervention
Neuroblastoma	Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vindesine Procedure: autologous hematopoietic stem cell transplantation Radiation: iobenguane I 131 Radiation: radiation therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Cyclophosphamide Vincristine Cisplatin Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Vindesine 3-Iodobenzylguanidine Iobenguane Etoposide phosphate Topotecan hydrochloride Filgrastim Topotecan Lenograstim Granulocyte colony-stimulating factor Melphalan Sarcolysin Vincristine sulfate Melphalan hydrochloride Ifosfamide Dacarbazine Isotretinoin Sodium iodide I 131

U.S. FDA Resources

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

Primary Outcome Measures:

Event-free survival (EFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS) [ Designated as safety issue: No ]
Impact of well established clinical and molecular risk factors on EFS and OS [ Designated as safety issue: No ]
Early response, measured after 2 courses of induction chemotherapy [ Designated as safety issue: No ]
Response to induction therapy, measured before autologous stem cell transplantation [ Designated as safety issue: No ]
Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy [ Designated as safety issue: Yes ]
Impact of the extent of initial and best surgery on outcome and frequency of complications [ Designated as safety issue: No ]
Acute and late toxicity of radiotherapy [ Designated as safety issue: Yes ]
Correlation of MIBG activity with whole-body radiation dose [ Designated as safety issue: No ]
Molecular markers (MYCN and status of chromosome 1p and 11q) [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of neuroblastoma according to any of the following criteria:
- Histological diagnosis from tumor tissue
- Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
High-risk disease, meeting 1 of the following criteria:
- Stage 4 disease, regardless of the MYCN status (1-21 years of age)
- Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age)

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Fertile patients must use effective contraception (hormonal contraception or intra-uterine device [IUD])

PRIOR CONCURRENT THERAPY:

No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial
No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526318

Show 69 Study Locations

Sponsors and Collaborators

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators

Study Chair:

Frank Berthold, MD

Children's Hospital Medical Center, Cincinnati

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00526318 History of Changes
Other Study ID Numbers:	CDR0000564820, GPOH-NB2004-HR, UNI-KOELN-161, EU-20661
Study First Received:	September 5, 2007
Last Updated:	September 1, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
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
Etoposide phosphate
Isophosphamide mustard
Cisplatin
Cyclophosphamide
Dacarbazine

Doxorubicin
Etoposide
Ifosfamide
Melphalan
Vincristine
Vindesine
3-Iodobenzylguanidine
Carboplatin
Topotecan
Lenograstim
Isotretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012