Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00055562

Collaborator

(none)

274

Enrollment

Locations

Duration (Months)

8.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Neoplasm Metastasis	Drug: CC 5013	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy

Study Start Date :

Jan 1, 2003

Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Understand and voluntarily sign an informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy.
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug.
Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Cancer Center	Tucson	Arizona	United States	85724
2	University of Southern California Norris Cancer Center	Los Angeles	California	United States	90089
3	UCLA	Los Angeles	California	United States	90095-6956
4	St. Francis Memorial Hospital	San Francisco	California	United States	94109
5	Outpatient Clinic	Santa Monica	California	United States	90404
6	University of Colorado	Aurora	Colorado	United States	80010
7	The Harold Lever Regional Cancer Center	Waterbury	Connecticut	United States	06708
8	Lakeland Regional Cancer Center	Lakeland	Florida	United States	33804-1057
9	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida	United States	33140
10	Lutheran General	Park Ridge	Illinois	United States	60068-1270
11	Carle Clinic	Urbana	Illinois	United States	61801
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02214-2698
13	Beth Israel Deaconess Medical Ctr	Boston	Massachusetts	United States	02215-5400
14	Spectrum Health	Grand Rapids	Michigan	United States	49503
15	Ellis Fischel Cancer Center	Columbia	Missouri	United States	65203
16	Washington University School of Medicine	St. Louis	Missouri	United States	63110
17	Melanoma Center of St Louis	St. Louis	Missouri	United States	63131
18	Biomedical Research Alliance of New York	New York	New York	United States	10016
19	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
20	The Linder Clinical Trial Center	Cincinnati	Ohio	United States	45219
21	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
22	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
23	UPMC Cancer Pavillion	Pittsburgh	Pennsylvania	United States	15232
24	Sarah Cannon Cancer Center	Nashville	Tennessee	United States	37203-1632
25	MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
26	Tom Baker Cancer Center	Calgary	Alberta	Canada	T2N 4N2
27	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
28	Cancer Care Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
29	Qell Health Sciences Center	Halifax	Nova Scotia	Canada	B3H 2y9
30	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
31	L'Hotel Dieu de Quebec	Quebec		Canada	PQ G1R 2J6