Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
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Purpose
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 |
Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Induction Regimen Incorporating Topotecan for Treatment of Newly Diagnosed High Risk Neuroblastoma |
| Study Start Date: | March 2004 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| 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:
- International Neuroblastoma Staging System (INSS) stage 2a/2b with MYCN amplification (greater than 10) AND unfavorable pathology
- INSS stage 3 with MYCN amplification OR unfavorable pathology
Newly diagnosed INSS stage 4 disease meeting criteria for 1 of the following:
- Over 18 months of age
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
- No INSS stage 4 disease and age 12 to 18 months with all 3 favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index greater than 1)
- Newly diagnosed INSS stage 3, 4, or 4S disease AND under 1 year of age with MYCN amplification
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
- Must have been enrolled on COG-ANBL00B1 at initial diagnosis
PATIENT CHARACTERISTICS:
Age
- 30 and under at initial diagnosis
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 100,000/mm^3* (transfusion independent)
- Hemoglobin at least 10.0 g/dL* (red blood cell transfusions allowed) NOTE: *Granulocytopenia, anemia, and/or thrombocytopenia allowed for patients with tumor metastatic to the bone marrow
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- ALT less than 300 IU/L
Renal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
Cardiovascular
- ECG normal
- Shortening fraction at least 27% by echocardiogram OR
- Ejection fraction at least 50% by MUGA
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No more than 1 prior chemotherapy course on the low- or intermediate-risk neuroblastoma studies (COG-P9641, COG-A3961) prior to determination of MYCN amplification and Shimada histology
Endocrine therapy
- Not specified
Radiotherapy
- Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed
Surgery
- Not specified
Other
- No other prior systemic therapy
Contacts and Locations| 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 | Seattle Children's Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00070200 History of Changes |
| Other Study ID Numbers: | CDR0000330140, COG-ANBL02P1 |
| Study First Received: | October 3, 2003 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent neuroblastoma stage 4S neuroblastoma localized unresectable neuroblastoma |
localized resectable neuroblastoma regional 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 Cisplatin Cyclophosphamide Doxorubicin Etoposide Melphalan |
Vincristine Topotecan Lenograstim Isotretinoin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013