NCT00022464

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2001

Typical duration for phase_2

Geographic Reach
2 countries

21 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

Study Start

First participant enrolled

June 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

4.3 years

First QC Date

August 10, 2001

Last Update Submit

June 3, 2015

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

temsirolimusDRUG

Eligibility Criteria

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

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

Sponsors & Collaborators

Study Sites (21)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-0269, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

LaGrange Memorial Hospital

LaGrange, Illinois, 60525, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 16007689RESULT

MeSH Terms

Conditions

Melanoma

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kim A. Margolin, MD

    City of Hope Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(18)CA(3)