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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003093 |
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. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study |
Estimated Enrollment: | 400 |
Study Start Date: | January 1988 |
OBJECTIVES:
OUTLINE: Patients receive carboplatin IV over 1 hour on days 0, 21, and 63; cyclophosphamide IV over 1 hour on days 21 and 42; doxorubicin IV over 15-60 minutes on days 21 and 63; and etoposide IV over 2 hours on days 0-2, 42-44, and 63-65. Patients under 60 days of age also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover. Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover. Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy (as below) and delay surgery to the primary site after completion of chemotherapy.
Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84, 105, and 147; etoposide IV over 2 hours on days 84-86 and 126-128; carboplatin IV over 1 hour on days 105 and 126; and doxorubicin IV over 15-60 minutes on days 105 and 147. Patients then undergo debulking surgery on day 168 or when blood counts recover.
Some patients may then undergo radiotherapy after surgery.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven neuroblastoma or maturing ganglioneuroma that is judged to be intermediate risk by one of the following criteria:
International Neuroblastoma Staging System (INSS) stage III
INSS stage IV
INSS stage IVS
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | David L. Baker, MD, MBBS, FRACP, FRCPA | Princess Margaret Hospital for Children |
Study ID Numbers: | CDR0000065804, COG-A3961, CCG-A3961, POG-A3961 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003093 History of Changes |
Health Authority: | United States: Federal Government |
regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma localized unresectable neuroblastoma |
Neuroectodermal Tumors, Primitive Immunologic Factors Cyclophosphamide Carboplatin Etoposide phosphate Immunosuppressive Agents Neuroblastoma Doxorubicin Anti-Bacterial Agents |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neuroblastoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type |
Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |