Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304083
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2006-03-15
Brief Title:
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
Sponsor:
Sarcoma Alliance for Research through Collaboration
Organization:
Sarcoma Alliance for Research through Collaboration
Study Overview
Official Title:
Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Nerve Sheath Tumors
Status:
COMPLETED
Status Verified Date:
2018-05
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:
RATIONALE Drugs used in chemotherapy such as doxorubicin ifosfamide and etoposide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with stage III or stage IV malignant peripheral nerve sheath tumors
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with stage III or stage IV malignant peripheral nerve sheath tumors
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate complete and partial in patients with sporadic or neurofibromatosis type 1 NF1-associated high-grade stage III or IV malignant peripheral nerve sheath tumors MPNSTs after treatment with 4 courses of chemotherapy comprising doxorubicin hydrochloride and ifosfamide IA followed by etoposide and ifosfamide IE
Secondary
Evaluate the utility of fludeoxyglucose F18 positron emission tomography 18FDG-PET and automated MRI volumetric tumor analysis as tools to assess response to treatment
Correlate response evaluation by 2-dimensional WHO criteria 1-dimensional RECIST criteria 18FDG-PET and volumetric MRI with percent necrosis in tumor specimens from patients who undergo surgery for local control after chemotherapy
Evaluate the response of plexiform neurofibromas if present to chemotherapy using WHO criteria and automated volumetric MRI analysis
Evaluate the molecular biology of sporadic and NF1-associated MPNSTs by performing a detailed pathologic analysis of tumor samples with the goal to analyze if markers can be identified that predict for response to chemotherapy or outcome
Construct a tissue microarray from submitted tumor samples that will be used in the future to identify novel targets for treatment of MPNSTs
Assess if a serum biomarker can be identified that predicts for the presence of a MPNST versus benign plexiform neurofibroma
Increase the knowledge of the epidemiology and clinical presentation of NF1-associated MPNSTs
OUTLINE This is a multicenter study Patients are stratified according to type of malignant peripheral nerve sheath tumor MPNST sporadic MPNST vs neurofibromatosis type 1 NF1-associated MPNST Patients receive 1 of 2 treatment regimens depending on the location of the MPNST and tumor response to chemotherapy
Chemotherapy and local control by radiotherapy and surgery Patients receive doxorubicin hydrochloride and ifosfamide IA chemotherapy comprising doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 and ifosfamide IV over 1 hour on days 1-5 Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity Patients then receive etoposide and ifosfamide IE chemotherapy comprising etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients also receive filgrastim G-CSF subcutaneously SC after each chemotherapy course beginning on day 6 or 7 and continuing until blood counts recover or pegfilgrastim SC once on day 6 or 7
After recovery from chemotherapy patients undergo radiotherapy and receive 2 more courses of IE during radiotherapy followed by 2 more courses of IA after completion of radiotherapy Some patients may then undergo surgery
Chemotherapy and local control by surgery Patients receive 2 courses of IA followed by 2 courses of IE as above After recovery from chemotherapy patients undergo surgery After recovery from surgery patients receive 2 more courses of IA followed by 2 more courses of IE in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 74 patients will be accrued for this study
Primary
Determine the clinical response rate complete and partial in patients with sporadic or neurofibromatosis type 1 NF1-associated high-grade stage III or IV malignant peripheral nerve sheath tumors MPNSTs after treatment with 4 courses of chemotherapy comprising doxorubicin hydrochloride and ifosfamide IA followed by etoposide and ifosfamide IE
Secondary
Evaluate the utility of fludeoxyglucose F18 positron emission tomography 18FDG-PET and automated MRI volumetric tumor analysis as tools to assess response to treatment
Correlate response evaluation by 2-dimensional WHO criteria 1-dimensional RECIST criteria 18FDG-PET and volumetric MRI with percent necrosis in tumor specimens from patients who undergo surgery for local control after chemotherapy
Evaluate the response of plexiform neurofibromas if present to chemotherapy using WHO criteria and automated volumetric MRI analysis
Evaluate the molecular biology of sporadic and NF1-associated MPNSTs by performing a detailed pathologic analysis of tumor samples with the goal to analyze if markers can be identified that predict for response to chemotherapy or outcome
Construct a tissue microarray from submitted tumor samples that will be used in the future to identify novel targets for treatment of MPNSTs
Assess if a serum biomarker can be identified that predicts for the presence of a MPNST versus benign plexiform neurofibroma
Increase the knowledge of the epidemiology and clinical presentation of NF1-associated MPNSTs
OUTLINE This is a multicenter study Patients are stratified according to type of malignant peripheral nerve sheath tumor MPNST sporadic MPNST vs neurofibromatosis type 1 NF1-associated MPNST Patients receive 1 of 2 treatment regimens depending on the location of the MPNST and tumor response to chemotherapy
Chemotherapy and local control by radiotherapy and surgery Patients receive doxorubicin hydrochloride and ifosfamide IA chemotherapy comprising doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 and ifosfamide IV over 1 hour on days 1-5 Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity Patients then receive etoposide and ifosfamide IE chemotherapy comprising etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients also receive filgrastim G-CSF subcutaneously SC after each chemotherapy course beginning on day 6 or 7 and continuing until blood counts recover or pegfilgrastim SC once on day 6 or 7
After recovery from chemotherapy patients undergo radiotherapy and receive 2 more courses of IE during radiotherapy followed by 2 more courses of IA after completion of radiotherapy Some patients may then undergo surgery
Chemotherapy and local control by surgery Patients receive 2 courses of IA followed by 2 courses of IE as above After recovery from chemotherapy patients undergo surgery After recovery from surgery patients receive 2 more courses of IA followed by 2 more courses of IE in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 74 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-2007CG077 | None | None | None |
| SARC-006 | None | None | None |
| NCI-06-C-0043 | None | None | None |
| NCI-P6452 | None | None | None |