CCI-779 in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022464
• Other study ID #: CDR0000068820
• Secondary ID: U01CA063265P30CA
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: June 3, 2015
• Start date: June 2001
• Est. completion date: September 2005

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• temsirolimus

Locations

Country	Name	City	State
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	LaGrange Memorial Hospital	LaGrange	Illinois
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Loyola University Medical Center	Maywood	Illinois
United States	Weill Medical College of Cornell University	New York	New York
United States	City of Hope Medical Group	Pasadena	California
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California Davis Cancer Center	Sacramento	California
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Margolin 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. — View Citation