NCT00066196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2003

Typical duration for phase_2

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

3.7 years

First QC Date

August 5, 2003

Last Update Submit

January 14, 2008

Conditions

MelanomaMalignant Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Determine the safety of MEDI-522 and/or DTIC in this patient population.

    Every week until disease progression, and 30 days after disease progression.

Study Arms (2)

2

OTHER

Integrin + Dacarbazine

Biological: Integrin + Dacarbazine

1

ACTIVE COMPARATOR

MEDI-522

Biological: MEDI--522

Interventions

MEDI--522BIOLOGICAL

IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.

1
Integrin + DacarbazineBIOLOGICAL

supplied in other formulations

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 β human chorionic gonadotropin (βhCG) 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.

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Saint Francis Memorial Hospital

San Francisco, California, 94109, United States

Location

Cancer Institute Medical Group

Santa Monica, California, 90404, United States

Location

Medical Group of North County

Vista, California, 92083, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60069, United States

Location

Indiana Oncology Hematology Consultants

Indianapolis, Indiana, 46202, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University - SKCC at Johns Hopkins

Lutherville, Maryland, 21093, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Kansas City Oncology & Hematology Group

Kansas City, Missouri, 64131, United States

Location

The Melanoma Center of St. Louis

St Louis, Missouri, 63131, United States

Location

HemOnc Care, P.C.

Brooklyn, New York, 11235, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Blumenthal Cancer Center

Charlotte, North Carolina, 28203, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Discovery Alliance

Houston, Texas, 77030, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

etaracizumabIntegrinsDacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Receptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luz Hammershaimb, M.D.

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2003

First Posted

August 7, 2003

Study Start

August 1, 2003

Primary Completion

April 1, 2007

Study Completion

June 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(25)