A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors

NCT00001209 | Completed Phase 1

• 2 other identifiers: 86016986-C-0169
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroectodermal Tumor, Primitive; Neuroepithelioma; Osteosarcoma; Sarcoma; Sarcoma, Ewing's

Keywords

Combined Chemotherapy; Irradiation; Unresectable

Interventions

vincristine, adriamycin and cytoxan, alternating with ifosfamide VP-16 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors; Osteosarcoma; Sarcoma; Sarcoma, Ewing

Interventions

Vincristine; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: October 1, 1986
• Study Completion: August 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-09

Locations

US (1)