CCI-779 in Treating Patients With Advanced Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003712
• Other study ID #: CDR0000066820
• Secondary ID: P30CA054174UTHSC
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: August 7, 2012
• Start date: January 2001
• Est. completion date: June 2002

Study information

• Verified date: August 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Nervous System Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• temsirolimus
•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.

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	San Antonio Cancer Institute	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Cancer Institute (NCI), University of Texas, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States,