CCI-779 in Treating Patients With Advanced Solid Tumors

NCT00003712

Last updated date
Study Location
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain and Central Nervous System Tumors, Metastatic Cancer, Protocol Specific Unspecified Adult Solid Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Brain and Central Nervous System Tumors, Metastatic Cancer, Protocol Specific Unspecified Adult Solid TumorCCI-779 in Treating Patients With Advanced Solid Tumors
NCT00003712
  1. Rochester, Minnesota
  2. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE CCI-779 in Treating Patients With Advanced Solid Tumors
Official Title  ICMJE 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
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE 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.

Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
15
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2002
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003712
Other Study ID Numbers  ICMJE CDR0000066820
P30CA054174 ( U.S. NIH Grant/Contract )
UTHSC-9785011303 ( Other Identifier: UTHSCSA IRB )
SACI-IDD-98-02 ( Other Identifier: San Antonio Cancer Institute )
W-AR-3066K1-100-US ( Other Identifier: Wyeth )
NCI-V98-1506 ( Other Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • University of Texas
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Chair:Eric K. Rowinsky, MDSan Antonio Cancer Institute
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP