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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070109 |
RATIONALE: Drugs used in chemotherapy such as ecteinascidin 743 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ecteinascidin 743 works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: trabectedin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcoma |
Estimated Enrollment: | 60 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma family of tumors vs rhabdomyosarcoma vs nonrhabdomyosarcomatous soft tissue sarcoma).
Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 30-60 patients (10-20 per stratum) will be accrued for this study within 2 years.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or refractory sarcomas, including the following:
Measurable disease by imaging studies
No significant amount of metastatic liver disease, defined as the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Maximum creatinine based on age as follows:
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent CYP3A4 inhibitors, including the following:
Study Chair: | Sylvain Baruchel, MD | The Hospital for Sick Children |
Study ID Numbers: | CDR0000329999, COG-ADVL0221 |
Study First Received: | October 3, 2003 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00070109 |
Health Authority: | Unspecified |
recurrent childhood rhabdomyosarcoma previously treated childhood rhabdomyosarcoma recurrent childhood soft tissue sarcoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Ecteinascidin 743 Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Ewing's family of tumors Osteosarcoma Osteogenic sarcoma Recurrence Soft tissue sarcomas Neuroectodermal Tumors |
Neoplasms, Connective and Soft Tissue Ewing's sarcoma Sarcoma, Ewing's Peripheral neuroectodermal tumor Sarcoma Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Rhabdomyosarcoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms, Bone Tissue Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Myosarcoma Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Connective Tissue Alkylating Agents Pharmacologic Actions |