NCT00003712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 15, 2003

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

November 1, 1999

Last Update Submit

August 7, 2012

Conditions

Brain and Central Nervous System TumorsMetastatic CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

recurrent adult brain tumorunspecified adult solid tumor, protocol specifictumors metastatic to brain

Interventions

temsirolimusDRUG

•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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

San Antonio Cancer Institute

San Antonio, Texas, 78229-3264, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsNeoplasm MetastasisBrain Neoplasms

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Eric K. Rowinsky, MD

    San Antonio Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 15, 2003

Study Start

January 1, 2001

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

US(2)