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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA054174 | U.S. NIH Grant/Contract | View source | |
| UTHSC-9785011303 | Other Identifier | UTHSCSA IRB | |
| SACI-IDD-98-02 | Other Identifier | San Antonio Cancer Institute | |
| W-AR-3066K1-100-US | Other Identifier | Wyeth | |
| NCI-V98-1506 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Texas | OTHER |
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temsirolimus | Drug | •Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity. •Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II. |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Eric K. Rowinsky, MD | San Antonio Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States | ||
| San Antonio Cancer Institute |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
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| San Antonio |
| Texas |
| 78229-3264 |
| United States |
| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |