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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Eric K. Rowinsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Antonio Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066820

NCT ID:

NCT00003712

Start Date:

January 2001

Completion Date:

June 2002

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • recurrent adult brain tumor
  • unspecified adult solid tumor, protocol specific
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
San Antonio Cancer InstituteSan Antonio, Texas  78229-3264