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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Malignant Metastatic Melanoma

Thank you

Trial Information

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


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).

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.

Outcome Time Frame:

Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.

Safety Issue:

No

Principal Investigator

Luz Hammershaimb, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

MI-CP095

NCT ID:

NCT00066196

Start Date:

August 2003

Completion Date:

June 2007

Related Keywords:

  • Melanoma
  • Malignant Metastatic Melanoma
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Boston Medical CenterBoston, Massachusetts  02118
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Pacific Shores Medical GroupLong Beach, California  90813
Saint Francis Memorial HospitalSan Francisco, California  94109
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Providence Portland Medical CenterPortland, Oregon  97213-3635
Indiana University Medical CenterIndianapolis, Indiana  46202
Medical Group of North CountyVista, California  92083
Blumenthal Cancer CenterCharlotte, North Carolina  28203
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Cancer Institute Medical GroupLos Angeles, California  90025
University of MiamiMiami, Florida  33136
Yale University School Of MedicineNew Haven, Connecticut  06520
Indiana Oncology Hematology ConsultantsIndianapolis, Indiana  46202
Mayo Clinic ArizonaScottsdale, Arizona  85259
Johns Hopkins University - SKCC at Johns HopkinsLutherville, Maryland  21093
Kansas City Oncology & Hematology GroupKansas City, Missouri  64131
The Melanoma Center of St. LouisSt. Louis, Missouri  63131
HemOnc Care, P.C.Brooklyn, New York  11235
UNC-Chapel HillChapel Hill, North Carolina  27599
The University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Discovery AllianceHouston, Texas  77030