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CCI-779 in Treating Patients With Metastatic Melanoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00022464
Enrollment
Unknown
Registered
2003-01-27
Start date
2001-06-30
Completion date
2005-09-30
Last updated
2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma, recurrent melanoma

Brief 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.

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.

Interventions

DRUGtemsirolimus

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
City of Hope Medical Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026