CCI-779 in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00022464
First received: August 10, 2001
Last updated: February 5, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Melanoma (Skin)
Drug: temsirolimus
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Study Start Date: June 2001
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022464

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00022464     History of Changes
Other Study ID Numbers: CDR0000068820, U01CA063265, P30CA033572, CHNMC-PHII-27, CHNMC-IRB-99167, NCI-29
Study First Received: August 10, 2001
Last Updated: February 5, 2010
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014