CCI-779 in Treating Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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recurrent adult brain tumor unspecified adult solid tumor, protocol specific tumors metastatic to brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric K. Rowinsky, MD

Role: STUDY_CHAIR

San Antonio Cancer Institute

Locations

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Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

San Antonio Cancer Institute

San Antonio, Texas, United States

Site Status

Countries

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United States