Clinical trial · Interventional
CCI-779 in Treating Patients With Metastatic Melanoma
A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma
NCT00022464CI-TRIAL-00018192completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 P450-3AReferences
Publications (1)
- RESULTMargolin K, Longmate J, Baratta T, Synold T, Christensen S, Weber J, Gajewski T, Quirt I, Doroshow JH. CCI-779 in metastatic melanoma: a phase II trial of the California Cancer Consortium. Cancer. 2005 Sep 1;104(5):1045-8. doi: 10.1002/cncr.21265. PMID 16007689