CCI-779 in Treating Patients With Metastatic Melanoma

June 3, 2015 updated by: City of Hope Medical Center

A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068820
  • P30CA033572 (U.S. NIH Grant/Contract)
  • U01CA063265 (U.S. NIH Grant/Contract)
  • CHNMC-PHII-27
  • CHNMC-IRB-99167
  • NCI-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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