A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001209 |
Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroectodermal Tumor, Primitive Neuroepithelioma Osteosarcoma Sarcoma Sarcoma, Ewing's | Drug: vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors |
Study Start Date : | October 1986 |
Study Completion Date : | August 2000 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001209
United States, Maryland | |
National Cancer Institute (NCI) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001209 |
Other Study ID Numbers: |
860169 86-C-0169 |
First Posted: | December 10, 2002 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | September 1999 |
Combined Chemotherapy Irradiation Unresectable |
Sarcoma Osteosarcoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Sarcoma, Ewing Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |
Cyclophosphamide Ifosfamide Vincristine Doxorubicin Liposomal doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |