Clincosm LogoSign in Get a demo

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

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00066196
Collaborator
(none)
110
Enrollment
25
Locations
2
Arms
46
Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: MEDI--522
  • Biological: Integrin + Dacarbazine
 Phase 2

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Aug 1, 2003
Anticipated Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Other: 2

Integrin + Dacarbazine

Biological: Integrin + Dacarbazine
supplied in other formulations
Active Comparator: 1

MEDI-522

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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 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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Arizona Scottsdale Arizona United States 85259
2 Pacific Shores Medical Group Long Beach California United States 90813
3 Saint Francis Memorial Hospital San Francisco California United States 94109
4 Cancer Institute Medical Group Santa Monica California United States 90404
5 Medical Group of North County Vista California United States 92083
6 Yale University School of Medicine New Haven Connecticut United States 06520
7 University of Miami Miami Florida United States 33136
8 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
9 Oncology Specialists, S.C. Park Ridge Illinois United States 60069
10 Indiana Oncology Hematology Consultants Indianapolis Indiana United States 46202
11 Indiana University Medical Center Indianapolis Indiana United States 46202
12 Johns Hopkins University - SKCC at Johns Hopkins Lutherville Maryland United States 21093
13 Boston Medical Center Boston Massachusetts United States 02118
14 Kansas City Oncology & Hematology Group Kansas City Missouri United States 64131
15 The Melanoma Center of St. Louis St. Louis Missouri United States 63131
16 HemOnc Care, P.C. Brooklyn New York United States 11235
17 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
18 UNC-Chapel Hill Chapel Hill North Carolina United States 27599
19 Blumenthal Cancer Center Charlotte North Carolina United States 28203
20 Providence Portland Medical Center Portland Oregon United States 97213
21 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
22 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15232
23 Vanderbilt University Medical Center Nashville Tennessee United States 37232
24 Discovery Alliance Houston Texas United States 77030
25 The University of Texas, MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • MedImmune LLC

Investigators

  • Study Director: Luz Hammershaimb, M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00066196
Other Study ID Numbers:
  • MI-CP095
  • NCT00081081
First Posted:
Aug 7, 2003
Last Update Posted:
Jan 15, 2008
Last Verified:
Jan 1, 2008
Additional relevant MeSH terms:
Melanoma
Dacarbazine

Study Results

No Results Posted as of Jan 15, 2008