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Sponsored by: |
San Antonio Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003712 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific |
Drug: temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | July 1998 |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study within 8 months, and 12 patients will be accrued for part II within 7 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Part I:
Part II:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Texas | |
San Antonio Cancer Institute | |
San Antonio, Texas, United States, 78229-3264 |
Study Chair: | Eric K. Rowinsky, MD | San Antonio Cancer Institute |
Study ID Numbers: | CDR0000066820, UTHSC-9785011303, SACI-IDD-98-02, W-AR-3066K1-100-US, NCI-V98-1506 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003712 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor unspecified adult solid tumor, protocol specific adult tumors metastatic to brain |
Brain Neoplasms Central Nervous System Neoplasms Recurrence Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases Central Nervous System Neoplasms Nervous System Neoplasms |