Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-06-30
2005-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma.
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Detailed Description
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* Determine the anti-tumor activity of CCI-779, in terms of progression-free survival, in patients with metastatic melanoma.
* Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive CCI-779 IV over 30 minutes on day 1. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: Approximately 40-50 patients will be accrued for this study within 12 months.
Conditions
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Study Design
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TREATMENT
Interventions
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temsirolimus
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion
* Measurable disease
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* The following are not considered measurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Progressive disease
* No prior or concurrent CNS metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 4 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal
* Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed)
* Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A reductase inhibitors
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No prior allergic reactions to compounds of similar chemical or biological composition to study drug
* No ongoing or active infection
* No seizure disorder
* No autoimmune disease
* No psychiatric illness or social situation that would preclude study
* No other concurrent uncontrolled illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior adjuvant biological therapy regimen
* No more than 1 prior biological therapy regimen for advanced disease
* At least 6 months since prior biological therapy or biochemotherapy and recovered
* Prior isolated limb perfusion with biological agent allowed if not to sole site of disease
Chemotherapy:
* See Biologic therapy
* Prior isolated limb perfusion with chemotherapy allowed if not to sole site of disease
* No more than 1 prior chemotherapy-containing regimen for advanced disease, regardless of adjuvant therapy
* May be in addition to 1 prior biologic regimen for advanced disease OR
* May have had 1 prior biochemotherapy regimen for advanced disease
* At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy:
* At least 1 week since prior dexamethasone
* No concurrent glucocorticosteroid therapy
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
Other:
* At least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin
* At least 3 weeks since other prior agents to treat malignancy
* At least 3 weeks since prior investigational agents
* No other concurrent investigational agents
* No concurrent drugs that are metabolized by or alter the level of cytochrome P450-3A
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Principal Investigators
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Kim A. Margolin, MD
Role: STUDY_CHAIR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
City of Hope Medical Group
Pasadena, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
LaGrange Memorial Hospital
LaGrange, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
North Shore University Hospital
Manhasset, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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Margolin K, Longmate J, Baratta T, Synold T, Christensen S, Weber J, Gajewski T, Quirt I, Doroshow JH. CCI-779 in metastatic melanoma: a phase II trial of the California Cancer Consortium. Cancer. 2005 Sep 1;104(5):1045-8. doi: 10.1002/cncr.21265.
Other Identifiers
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CHNMC-PHII-27
Identifier Type: -
Identifier Source: secondary_id
CHNMC-IRB-99167
Identifier Type: -
Identifier Source: secondary_id
NCI-29
Identifier Type: -
Identifier Source: secondary_id
CDR0000068820
Identifier Type: -
Identifier Source: org_study_id
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