NCT00022464
CCI-779 in Treating Patients With Metastatic Melanoma
PHASE2
COMPLETED
NCT00022464
INTERVENTIONAL
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.
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
Melanoma (Skin)
- TREATMENT
-
- Type: DRUG
- Name: temsirolimus
- Description:
- Arm Group Labels:
- City of Hope Medical Center