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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: | NCT00070200 |
RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous stem cell transplantation followed by radiation therapy for newly diagnosed or progressive neuroblastoma.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Induction Regimen Incorporating Topotecan for Treatment of Newly Diagnosed High Risk Neuroblastoma |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, multicenter study. Patients are stratified according to diagnosis (newly diagnosed vs initially stage 1, 2, or 4S that progressed to stage 4 without interval chemotherapy).
Induction therapy: Patients receive 6 courses of induction therapy.
Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed neuroblastoma or ganglioneuroblastoma meeting 1 of the following staging criteria:
Newly diagnosed disease, at least 1 year of age, and meets criteria for 1 of the following:
Newly diagnosed INSS stage 4 disease meeting criteria for 1 of the following:
Age 12 to 18 months with any unfavorable biologic feature (MYCN amplification, unfavorable pathology, and/or DNA index=1) or any biologic feature that is indeterminant, unsatisfactory, or unknown
At least 1 year of age and initially diagnosed with INSS stage 1, 2, or 4S disease that progressed to stage 4 without interval chemotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0106 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | |
Chicago, Illinois, United States, 60614 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 | |
Mary Bridge Children's Hospital and Health Center - Tacoma | |
Tacoma, Washington, United States, 98405 | |
Australia, New South Wales | |
Westmead Hospital | |
Westmead, New South Wales, Australia, 2145 |
Study Chair: | Julie R. Park, MD | Children's Hospital and Regional Medical Center, Seattle |
Study ID Numbers: | CDR0000330140, COG-ANBL02P1 |
Study First Received: | October 3, 2003 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070200 |
Health Authority: | United States: Federal Government |
recurrent neuroblastoma stage 4S neuroblastoma localized unresectable neuroblastoma |
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma |
Melphalan Neuroectodermal Tumors, Primitive Vincristine Cyclophosphamide Etoposide phosphate Neuroblastoma Recurrence Doxorubicin Neuroectodermal Tumors |
Cisplatin Neoplasms, Germ Cell and Embryonal Isotretinoin Neuroepithelioma Topotecan Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Dermatologic Agents Alkylating Agents |