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Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033709 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Drug: temozolomide Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma |
Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed leiomyosarcoma
At least 1 unidimensionally measurable lesion documented on radiologic study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 |
Study Chair: | Robert N. Taub, MD, PhD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069314, CPMC-IRB-14323, NCI-G02-2060 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033709 |
Health Authority: | United States: Federal Government |
adult leiomyosarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage III uterine sarcoma |
stage IV uterine sarcoma recurrent uterine sarcoma uterine leiomyosarcoma stage IV adult soft tissue sarcoma |
Neoplasms, Connective and Soft Tissue Thalidomide Leiomyosarcoma Malignant mesenchymal tumor Sarcoma |
Uterine sarcoma Temozolomide Soft tissue sarcomas Recurrence |
Neoplasms, Muscle Tissue Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Bacterial Agents Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Leprostatic Agents |