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CCI-779 in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: August 29, 2009   History of Changes
Sponsored by: San Antonio Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003712
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: temsirolimus
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
Study Start Date: July 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003712

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Texas
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229-3264
Sponsors and Collaborators
San Antonio Cancer Institute
Investigators
Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066820, UTHSC-9785011303, SACI-IDD-98-02, W-AR-3066K1-100-US, NCI-V98-1506
Study First Received: November 1, 1999
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00003712     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
unspecified adult solid tumor, protocol specific
tumors metastatic to brain

Study placed in the following topic categories:
Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Neoplasms
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Nervous System Diseases
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009