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	Treatment or Intervention	Phase
Stage IV Melanoma Recurrent Melanoma	Drug: CCI-779  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Kim Allyson Margolin, MD,  Study Chair,  Beckman Research Institute   

Study ID Numbers:  CDR0000068820; CHNMC-PHII-27; CHNMC-IRB-99167; NCI-29
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022464
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08