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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00027716 |
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastatic sarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease (stratum I: soft tissue sarcoma not specified in stratum II, osteogenic sarcoma arising from soft tissues, or gastrointestinal stromal tumor vs stratum II: Ewing's sarcoma of soft tissue or bone, rhabdomyosarcoma, or osteogenic sarcoma of bone). (Stratum I closed to accrual as of 10/17/03.)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for stratum I within 5-11 months and 21-41 patients will be accrued for stratum II within 10.5-22 months. (Stratum I closed to accrual as of 10/17/03.)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stratum I (closed to accrual as of 10/17/03):
Stratum II:
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Stratum I (closed to accrual as of 10/17/03):
Stratum II:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Colorado | |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80010 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
University of Chicago Cancer Research Center | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Abramson Cancer Center at University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Robert Maki, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000069060, MSKCC-01073, NCI-1757 |
Study First Received: | December 7, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00027716 |
Health Authority: | United States: Federal Government |
metastatic osteosarcoma recurrent adult soft tissue sarcoma recurrent osteosarcoma adult rhabdomyosarcoma |
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor stage IV adult soft tissue sarcoma |
Neuroectodermal Tumors, Primitive Ewing's family of tumors Malignant mesenchymal tumor Bortezomib 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 Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |