Back to resultsA Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
Primary Purpose
Neuroectodermal Tumor, Primitive, Neuroepithelioma, Osteosarcoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16
Sponsored by
About this trial
This is an interventional treatment trial for Neuroectodermal Tumor, Primitive focused on measuring Combined Chemotherapy, Irradiation, Unresectable
Eligibility Criteria
Patients with high grade soft tissue sarcomas and either metastatic disease or stage III tumors including synovial sarcoma, malignant fibrous histiocytoma, hemangiopericytoma, malignant schwannoma (neurofibrosarcoma). Patients must not have been previously treated with chemotherapy or radiation therapy. The patients age must be less than or equal to 25 years. The patient (or their guardian if under 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected. Patients must have a direct bilirubin of less than 4.0 mg/dl. Patients must not have abnormal cardiac function (ejection fraction greater than 45% on MUGA scan with confirmation of shortening-fraction greater than 25% on echocardiography).
Sites / Locations
- National Cancer Institute (NCI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001209
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00001209
Brief Title
A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
Official Title
A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 1999
Overall Recruitment Status
Completed
Study Start Date
October 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
Detailed Description
This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroectodermal Tumor, Primitive, Neuroepithelioma, Osteosarcoma, Sarcoma, Sarcoma, Ewing's
Keywords
Combined Chemotherapy, Irradiation, Unresectable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with high grade soft tissue sarcomas and either metastatic disease or stage III tumors including synovial sarcoma, malignant fibrous histiocytoma, hemangiopericytoma, malignant schwannoma (neurofibrosarcoma).
Patients must not have been previously treated with chemotherapy or radiation therapy.
The patients age must be less than or equal to 25 years.
The patient (or their guardian if under 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected.
Patients must have a direct bilirubin of less than 4.0 mg/dl.
Patients must not have abnormal cardiac function (ejection fraction greater than 45% on MUGA scan with confirmation of shortening-fraction greater than 25% on echocardiography).
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
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