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CCI-779 in Treating Patients With Metastatic Melanoma

Sponsor
City of Hope Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00022464
Collaborator
National Cancer Institute (NCI) (NIH)
21
Locations
51
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • 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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma
Study Start Date :
Jun 1, 2001
Actual Primary Completion Date :
Sep 1, 2005
Actual Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Comprehensive Cancer Center Duarte California United States 91010-0269
    2 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90089
    3 City of Hope Medical Group Pasadena California United States 91105
    4 University of California Davis Cancer Center Sacramento California United States 95817
    5 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    6 Louis A. Weiss Memorial Hospital Chicago Illinois United States 60640
    7 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
    8 Evanston Northwestern Health Care - Evanston Hospital Evanston Illinois United States 60201
    9 Ingalls Memorial Hospital Harvey Illinois United States 60426
    10 LaGrange Memorial Hospital LaGrange Illinois United States 60525
    11 Loyola University Medical Center Maywood Illinois United States 60153
    12 Oncology/Hematology Associates of Central Illinois, P.C. Peoria Illinois United States 61602
    13 Central Illinois Hematology Oncology Center Springfield Illinois United States 62701
    14 Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne Indiana United States 46885-5099
    15 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    16 North Shore University Hospital Manhasset New York United States 11030
    17 Weill Medical College of Cornell University New York New York United States 10021
    18 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
    19 Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario Canada L8V 5C2
    20 Cancer Care Ontario-London Regional Cancer Centre London Ontario Canada N6A 4L6
    21 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Kim A. Margolin, MD, City of Hope Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00022464
    Other Study ID Numbers:
    • CDR0000068820
    • U01CA063265
    • P30CA033572
    • CHNMC-PHII-27
    • CHNMC-IRB-99167
    • NCI-29
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 8, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Sirolimus

    Study Results

    No Results Posted as of Jun 8, 2015