Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
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ClinicalTrials.gov Identifier: NCT00017225 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: August 2, 2013
|
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroblastoma | Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: melphalan Drug: tretinoin Drug: vincristine sulfate Drug: vindesine Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma |
Study Start Date : | May 1997 |
Actual Study Completion Date : | February 2002 |


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Ages Eligible for Study: | up to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed neuroblastoma
-
Observation stratum:
- MYCN gene not amplified
- Infants with stage I-IVS disease OR
- Over 1 year of age and stage I or II resectable disease
-
Standard-risk stratum:
- MYCN gene not amplified
- Infants with serious symptoms and stage II-IVS disease OR
- Over 1 year of age with stage II or III unresectable disease
-
High-risk stratum:
- Stage IV disease OR
- Stage I-IVS MYCN gene-amplified disease
PATIENT CHARACTERISTICS:
Age:
- 20 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- No kidney insufficiency
Cardiovascular:
- No cardiac insufficiency
Other:
- Not pregnant
- Fertile patients must use effective contraception
- No other serious illness
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy within 6 months after diagnosis
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017225

Study Chair: | Frank Berthold, MD | Children's Hospital Medical Center, Cincinnati |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00017225 History of Changes |
Other Study ID Numbers: |
GPOH-GERMANY-NB97 CDR0000068664 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20102 GER-GPOH-NB97 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | August 2, 2013 |
Last Verified: | August 2002 |
Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma |
stage 4S neuroblastoma recurrent 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 Melphalan Ifosfamide Liposomal doxorubicin Carboplatin |
Doxorubicin Etoposide Vincristine Tretinoin Vindesine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |