CCI-779 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00003712
First received: November 1, 1999
Last updated: August 7, 2012
Last verified: August 2012
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 The University of Texas Health Science Center at San Antonio:

Enrollment: 15
Study Start Date: January 2001
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The University of Texas Health Science Center at San Antonio
University of Texas
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00003712     History of Changes
Other Study ID Numbers: CDR0000066820, P30CA054174, UTHSC-9785011303, SACI-IDD-98-02, W-AR-3066K1-100-US, NCI-V98-1506
Study First Received: November 1, 1999
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
recurrent adult brain tumor
unspecified adult solid tumor, protocol specific
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014