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

Melanoma Clinical Trial

Official title:

A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066196
• Other study ID #: MI-CP095
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2003
• Last updated: January 14, 2008
• Start date: August 2003
• Est. completion date: June 2007

Study information

• Verified date: January 2008
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT00081081

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion

Patients must meet all of the following criteria at the time of randomization:

• Histologically confirmed, unresectable, Stage IV metastatic melanoma (AJCC staging), with at least one measurable lesion defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³ 10 mm with spiral computed tomography (CT) scan;

• Adult men and women of at least 18 years of age at the time of randomization;

• Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum ß human chorionic gonadotropin (ßhCG) pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), condom, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) at the time the informed consent is signed, and must agree to continue using such precautions while receiving MEDI-522 and for 30 days after the final dose of MEDI-522;

• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1;

• Life expectancy of at least 16 weeks;

• WBC = 3,000/mm3, absolute neutrophil count (ANC) = 1,500/mm3, platelet count = 100,000/mm3;

• Bilirubin = 1.5 mg/dL, aspartate transaminase (AST)/alanine transaminase (ALT) = 3 times upper limit of normal (ULN), serum creatinine = 1.5 mg/dL, alkaline phosphatase = 3.0 times ULN and prothrombin time (PT)/partial thromboplastin time (PTT) or international normalized ratio (INR) within normal range;

• Patients who have had prior treatment with adjuvant immunotherapy are eligible for study randomization provided that therapy ended at least 4 weeks prior to randomization;

• Patients who had prior surgery are eligible if at least 4 weeks have passed since their surgery;

• All toxicities related to prior adjuvant therapy must have resolved and all surgical wounds must have healed;

• Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.

Exclusion

Patients must have none of the following at the time of randomization:

• Pregnancy or nursing;

• Prior therapy for metastatic melanoma including chemotherapy, radiotherapy, hormonal therapy, or biologics;

• Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer;

• Current or planned participation (from the day of randomization through 30 days after the last dose of MEDI-522) in a research protocol in which an investigational agent or therapy may be administered;

• Received an investigational agent within 4 weeks prior to randomization;

• Known brain metastases or primary brain tumors, ocular melanoma, symptomatic pleural effusion or ascites requiring paracentesis;

• History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer;

• History of pulmonary embolus.

• Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (i.e., warfarin or heparin).

• Currently requiring therapeutic anticoagulation.

• Any evidence of hematemesis, melena, hematochezia, or gross hematuria;

• History or presence of bleeding diatheses;

• Elective surgery planned during the study period through 30 days after the last dose of MEDI-522.

• History of hypersensitivity to a previously administered monoclonal antibody.

• History of hypersensitivity to DTIC;

• History of immunodeficiency;

• Known human immunodeficiency virus (HIV) or known active viral hepatic infections;

• A prior myocardial infarction or angina, or uncontrolled/refractory hypertension within 6 months prior to randomization;

• A prior stroke or transient ischemic attack within the past 6 months;

• An active infection requiring systemic antiinfective therapy;

• Prior treatment with MEDI-522 or MEDI-523;

• A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Metastatic Melanoma
• Melanoma

Intervention

Biological:
• MEDI--522
IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
• Integrin + Dacarbazine
supplied in other formulations

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	HemOnc Care, P.C.	Brooklyn	New York
United States	UNC-Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center	Charlotte	North Carolina
United States	Discovery Alliance	Houston	Texas
United States	The University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	Indiana Oncology Hematology Consultants	Indianapolis	Indiana
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Kansas City Oncology & Hematology Group	Kansas City	Missouri
United States	Pacific Shores Medical Group	Long Beach	California
United States	Johns Hopkins University - SKCC at Johns Hopkins	Lutherville	Maryland
United States	University of Miami	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Saint Francis Memorial Hospital	San Francisco	California
United States	Cancer Institute Medical Group	Santa Monica	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	The Melanoma Center of St. Louis	St. Louis	Missouri
United States	Medical Group of North County	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Determine the safety of MEDI-522 and/or DTIC in this patient population.		Every week until disease progression, and 30 days after disease progression.	Yes