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CCI-779 in Treating Patients With Advanced Solid Tumors

Primary Purpose

Brain and Central Nervous System Tumors, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
temsirolimus
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, unspecified adult solid tumor, protocol specific, tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Part I: Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I) Measurable or evaluable disease Part II: Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists Receiving anticonvulsants Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases) Renal: Creatinine less than 2 mg/dL Cardiovascular: No unstable angina No myocardial infarction within past 6 months No maintenance therapy for life-threatening arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection or other serious concurrent illness Triglycerides no greater than 300 mg/dL Cholesterol no greater than 350 mg/dL No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed No concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 1 month since prior investigational agents At least 3 weeks since prior immunosuppressive therapy No concurrent anticonvulsant therapy (part I) No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide) No known agents that inhibit or induce cytochrome p450

Sites / Locations

  • Mayo Clinic Cancer Center
  • San Antonio Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 7, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI), University of Texas, Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00003712
Brief Title
CCI-779 in Treating Patients With Advanced Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI), University of Texas, Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Determine the safety, tolerability, and maximum tolerated dose (MTD) of CCI-779 in patients with advanced solid tumors (part I) who are not receiving anticonvulsant therapy. Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain metastases (part II) who are receiving anticonvulsant therapy. Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients. OUTLINE: This is an open-label, dose-escalation study. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
recurrent adult brain tumor, unspecified adult solid tumor, protocol specific, tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temsirolimus
Intervention Description
•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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Part I: Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I) Measurable or evaluable disease Part II: Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists Receiving anticonvulsants Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases) Renal: Creatinine less than 2 mg/dL Cardiovascular: No unstable angina No myocardial infarction within past 6 months No maintenance therapy for life-threatening arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection or other serious concurrent illness Triglycerides no greater than 300 mg/dL Cholesterol no greater than 350 mg/dL No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed No concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 1 month since prior investigational agents At least 3 weeks since prior immunosuppressive therapy No concurrent anticonvulsant therapy (part I) No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide) No known agents that inhibit or induce cytochrome p450
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric K. Rowinsky, MD
Organizational Affiliation
San Antonio Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
San Antonio Cancer Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3264
Country
United States

12. IPD Sharing Statement

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CCI-779 in Treating Patients With Advanced Solid Tumors

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