CCI-779 in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sirolimus

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