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| Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033709 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| 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 |
|
Thalidomide Immunologic Factors Leiomyosarcoma Temozolomide Immunosuppressive Agents Angiogenesis Inhibitors Recurrence Neoplasms, Connective and Soft Tissue |
Anti-Bacterial Agents Malignant Mesenchymal Tumor Soft Tissue Sarcomas Uterine Sarcoma Sarcoma Antineoplastic Agents, Alkylating Alkylating Agents |
|
Anti-Infective Agents Neoplasms, Muscle Tissue Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Leiomyosarcoma Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Temozolomide |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Leprostatic Agents |