Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma; Malignant Metastatic Melanoma
• Interventions: Biological: Integrin + Dacarbazine; Biological: MEDI--522

• Registration Number: NCT00066196
• Lead Sponsor: MedImmune LLC

Brief Summary

The primary objectives of this study are:

* To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma.

* To determine the safety of MEDI-522 ± DTIC in this patient population.

Detailed Description

This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2003-08-05
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Primary Completion: 2007-04
• Study Completion: 2007-06
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-14
• Last Update Posted: 2008-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Integrin + Dacarbazine	Integrin + Dacarbazine
1	MEDI--522	MEDI-522

Primary Outcome Measures

Name	Time	Method
Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.	Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.

Secondary Outcome Measures

Name	Time	Method
Determine the safety of MEDI-522 and/or DTIC in this patient population.	Every week until disease progression, and 30 days after disease progression.

Trial Locations

Locations (25)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Johns Hopkins University - SKCC at Johns Hopkins; 🇺🇸 Lutherville, Maryland, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Cancer Institute Medical Group; 🇺🇸 Santa Monica, California, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

Saint Francis Memorial Hospital; 🇺🇸 San Francisco, California, United States

Indiana Oncology Hematology Consultants; 🇺🇸 Indianapolis, Indiana, United States

Oncology Specialists, S.C.; 🇺🇸 Park Ridge, Illinois, United States

Discovery Alliance; 🇺🇸 Houston, Texas, United States

Medical Group of North County; 🇺🇸 Vista, California, United States

UNC-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

The Melanoma Center of St. Louis; 🇺🇸 St. Louis, Missouri, United States

University of Pittsburgh Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Kansas City Oncology & Hematology Group; 🇺🇸 Kansas City, Missouri, United States

HemOnc Care, P.C.; 🇺🇸 Brooklyn, New York, United States

The University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

Blumenthal Cancer Center; 🇺🇸 Charlotte, North Carolina, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States