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| Sponsor: | San Antonio Cancer Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003712 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors Metastatic Cancer 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.
The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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: | August 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003712 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor unspecified adult solid tumor, protocol specific tumors metastatic to brain |
|
Neoplastic Processes Neoplasms Neoplasms by Site Pathologic Processes |
Nervous System Diseases Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms |