Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165139
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-09-09
Brief Title:
Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Double Dose Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Stage Neuroblastoma and Sarcomas
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to determine the short and long term side effects of a very intensive treatment which includes combinations of chemotherapy drugs followed by radiation therapy and two transplants supported by peripheral blood progenitor cells stem cells for children with advanced stage neuroblastoma and sarcomas
Detailed Description:
The treatment is separated into three stages 1 Initial treatment-chemotherapy and stem cell collection 2 Treatment targeted directly to the main tumor-surgery and radiation therapy 3 Intensified treatment two stem cell transplants
Patients will receive intensive treatment with a combination of seven drugs which will be given every 3 weeks or as soon as the patients blood counts are within safe limits A total of 5 or 6 courses of chemotherapy will be given The third and fourth course will be followed by stem cell collections and the last course will be followed by bone marrow harvest in preparation for transplant
The first treatment involves a high-dose of Cisplatin intravenously once a day for 5 days and VP-16 intravenously on days 23 and 4 of the treatment
The second course of treatment involves cyclophosphamide intravenously on day 1 and day 2 adriamycin intravenously continuously over 48 hours and vincristine intravenously on day 1
The third course of treatment involves ifosfamide daily on days 1-5 and VP-16 on days 1-3 Mesna will also be given to prevent bladder irritation
During the fourth course patients will receive carboplatin intravenously on days 1 and 2 and VP-16 on days 12 and 3 of treatment
The fifth course of treatment will be identical to the second course
G-CSF granulocyte colony-stimulating factor stimulates bone marrow to produce more white blood cells and will be given subcutaneously until the patients white blood cell counts are at an acceptable level This may require 10-14 days of G-CSF treatment
After the first two treatments and after the last course of treatment patients will be evaluated for response If significant tumor is still present in the bone marrow before the third treatment stem cell collection will be delayed If the bone marrow still shows disease after the next treatment this plan of treatment will be stopped
Patients may undergo surgery after the last treatment to remove the tumor and to evaluate the remaining disease After recovery radiation therapy may be performed to the main tumor area
Patients will receive transplantations of stem cells twice during this study After each preparative treatment half of the patients stored stem cells will be given intravenously Until the stem cells restore safe levels of blood cells the patient will be hospitalized 3-4 weeks or longer
The first treatment will begin with high doses of carboplatin and VP-16 daily for 3 consecutive days followed by cyclophosphamide on the fourth and fifth days
Between 4-6 weeks after the start of the first course of high dose chemotherapy a second course consisting of melphalan and total body irradiation TBI will be given Melphalan will be given daily for 3 consecutive days followed by TBI twice a day for 3 days
After each of the two high dose treatments outlined above the stem cells that were previously harvested from the patient will be given back to them through a central line
Stem cells will be collected on 3 separate occasions following each of two cycles of chemotherapy They will then be processed using a technique that attempts to separate stem cells from other cells including any cancer cells that may be present
Bone marrow will also be harvested prior to the first transplant and will be used if blood counts do not recover after the stem cells are given
Patients will receive intensive treatment with a combination of seven drugs which will be given every 3 weeks or as soon as the patients blood counts are within safe limits A total of 5 or 6 courses of chemotherapy will be given The third and fourth course will be followed by stem cell collections and the last course will be followed by bone marrow harvest in preparation for transplant
The first treatment involves a high-dose of Cisplatin intravenously once a day for 5 days and VP-16 intravenously on days 23 and 4 of the treatment
The second course of treatment involves cyclophosphamide intravenously on day 1 and day 2 adriamycin intravenously continuously over 48 hours and vincristine intravenously on day 1
The third course of treatment involves ifosfamide daily on days 1-5 and VP-16 on days 1-3 Mesna will also be given to prevent bladder irritation
During the fourth course patients will receive carboplatin intravenously on days 1 and 2 and VP-16 on days 12 and 3 of treatment
The fifth course of treatment will be identical to the second course
G-CSF granulocyte colony-stimulating factor stimulates bone marrow to produce more white blood cells and will be given subcutaneously until the patients white blood cell counts are at an acceptable level This may require 10-14 days of G-CSF treatment
After the first two treatments and after the last course of treatment patients will be evaluated for response If significant tumor is still present in the bone marrow before the third treatment stem cell collection will be delayed If the bone marrow still shows disease after the next treatment this plan of treatment will be stopped
Patients may undergo surgery after the last treatment to remove the tumor and to evaluate the remaining disease After recovery radiation therapy may be performed to the main tumor area
Patients will receive transplantations of stem cells twice during this study After each preparative treatment half of the patients stored stem cells will be given intravenously Until the stem cells restore safe levels of blood cells the patient will be hospitalized 3-4 weeks or longer
The first treatment will begin with high doses of carboplatin and VP-16 daily for 3 consecutive days followed by cyclophosphamide on the fourth and fifth days
Between 4-6 weeks after the start of the first course of high dose chemotherapy a second course consisting of melphalan and total body irradiation TBI will be given Melphalan will be given daily for 3 consecutive days followed by TBI twice a day for 3 days
After each of the two high dose treatments outlined above the stem cells that were previously harvested from the patient will be given back to them through a central line
Stem cells will be collected on 3 separate occasions following each of two cycles of chemotherapy They will then be processed using a technique that attempts to separate stem cells from other cells including any cancer cells that may be present
Bone marrow will also be harvested prior to the first transplant and will be used if blood counts do not recover after the stem cells are given
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None