Phase II Study of Marrow Ablative Chemotherapy Followed by Rescue with Peripheral Blood Stem Cells, Radiotherapy, and Isotretinoin in Patients with High Risk Neuroblastoma (Summary Last Modified 04/1999)
Chemotherapy, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Children With High-Risk Neuroblastoma
Basic Trial Information
|Phase II||Treatment||Closed||Under 21||NCI||POG-9640|
I. Determine the response rates and overall survival of patients with high risk neuroblastoma following treatment with high dose cisplatin, vincristine, etoposide, cyclophosphamide, doxorubicin, ifosfamide, and carboplatin followed by autologous stem cell transplantation and radiation therapy. II. Determine the side effects, short and long term, of the treatment in these patients. III. Assess the relationship of biological features of neuroblastoma as determined on protocol POG-9047, to clinical presentation, response to therapy, and survival.
Histologically confirmed high risk neuroblastoma - Newly diagnosed high risk neuroblastoma patients previously registered no more than 2 weeks earlier on POG-9047 or its successor - Newly diagnosed high risk neuroblastoma patients who have received one course of chemotherapy on POG-9641 or A3961 - Relapsed or progressive neuroblastoma patients previously enrolled on POG 9641 who have received NO prior chemotherapy or radiotherapy and were originally low risk at diagnosis, who at relapse are high risk May not register on this protocol more than one time High risk neuroblastoma including: Stage IIA or IIB, older than 365 days of age with N-myc amplified, unfavorable histology with any ploidy Stage III under 365 days of age with N-myc amplification Stage III older than 365 days with N-myc amplification or with nonamplified N-myc but unfavorable histology Stage IV under 365 days of age with N-myc amplification Stage IV over 365 days of age regardless of N-myc or histology Stage IVS with N-myc amplification
See Disease Characteristics
Age: See Disease Characteristics Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
There will be 30 patients accrued into this study in 1.5 years.
Patients are stratified by disease status. Patients receive the following five 21-day courses of induction chemotherapy: Course 1 (week 0) - Cisplatin IV over 1 hour every day for 5 days and etoposide IV over 1 hour every 12 hours for 6 doses beginning just prior to cisplatin on day 2. Course 2 (week 3) - Vincristine IV push on days 1, 8, and 15, doxorubicin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour after doxorubicin on day 1 and again on day 2. Course 3 (week 6) - Etoposide IV over 1 hour every 12 hours for 3 days and ifosfamide IV over 1 hour days 1-5. Course 4 (week 9) - Etoposide IV over 1 hour every 12 hours for 3 days, carboplatin IV over 5 hours after etoposide on days 1 and 2. Course 5 (week 12) - High dose cisplatin and etoposide as in course 1. Patients are assessed for disease response after the third and fifth courses of treatment. If there is tumor response, patients undergo surgery 3 weeks after completion of induction chemotherapy. Patients not eligible for stem cell transplantation receive postinduction chemotherapy consisting of induction therapy courses, except in a different order: course 3, course 2, course 1, course 2, and course 4. After recovery from the last course of chemotherapy, patients undergo ablation chemotherapy. Patients receive etoposide by continuous IV infusion over 72 hours on days -6 through -4, carboplatin IV over 1 hour each day for three days on days -6 to -4, and cyclophosphamide IV over 1 hour each day for 2 days. On day 0, patients receive peripheral blood stem cell (PBSC) infusion. Patients then receive filgrastim (G-CSF) IV daily until absolute neutrophil count is greater than 1,000/mm3 for 2 days. The second course of ablation therapy consists of thiotepa IV over 2 hours on days -6 to -4 and cyclophosphamide IV over 1 hour every 8 hours for 12 doses on days -4 to -1. PBSC infusion occurs on day 0. G-CSF begins on day 3. Following ablation chemotherapy and the second stem cell rescue, patients receive local irradiation to the primary tumor bed. After radiotherapy, on or about 84 days after the second stem cell rescue, patients receive oral isotretinoin twice daily for 14 consecutive days followed by 14 days rest. Isotretinoin treatment is repeated for 6 courses or 24 weeks. Patients are followed every month for the first year, then every 3 months for the second year, then every 6 months for years 3-10, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations
Pediatric Oncology Group
Ph: 617-632-5642; 866-790-4500
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.