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Phase I Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin), a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Advanced Malignant Melanoma

Phase 1
18 Years
Not Enrolling
Malignant Melanoma

Thank you

Trial Information

Phase I Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin), a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Advanced Malignant Melanoma

Inclusion Criteria:

- Histologically confirmed, unresectable, Stage IV or recurrent malignant melanoma
(based on American Joint Committee on Cancer [AJCC] staging)

- Prior therapy with chemotherapy and/or immunotherapy for malignant melanoma is
allowed, provided that therapy ended prior to study entry and all treatment related
toxicities have resolved

- Measurable disease (based on Response Evaluation Criteria in Solid Tumors [RECIST]
criteria) defined as at least one lesion that can be accurately measured in at least
one dimension (longest diameter to be recorded) as greater than or equal to 20 mm
with conventional techniques, or as greater than or equal to 10 mm with a spiral
computed tomography (CT) scan

- Have melanoma that can be biopsied once before, and at least twice after, MEDI-522

- Males and females of at least 18 years of age at the time of study entry

- Women of reproductive potential (defined as being <1 year post-menopausal) must have
a negative serum B human chorionic gonadotropin (bHCG) pregnancy test within 3 days
prior to study entry; 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 informed consent is
signed (women only) or at the time of the initiation of MEDI-522 (men only), 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 greater than or equal to 3000/mm(3), absolute neutrophil count (ANC) greater than
or equal to 1,500/mm(3), platelet count greater than or equal to 100,000/mm(3)

- Bilirubin greater than or equal to 1.5 mg/dL [unless due to Gilbert's syndrome
(unconjugated hyperbilirubinemia) in which case the bilirubin should be <= 3.5
mg/dL]; aspartate transaminase (AST)/alanine transaminase (ALT) greater than or equal
to 3 x upper limit of normal (ULN); serum creatinine greater than or equal to 1.5
mg/dL; hepatic alkaline phosphatase greater than or equal to 3.0 x ULN; prothrombin
time (PT) or international normalized ratio (INR) within normal range (unless a
patient is receiving anticoagulation therapy); or partial thromboplastin time (PTT)
within normal range

- Patients who have had prior radiation therapy are eligible, provided that therapy was
palliative in nature, not in the area where the tumor will be biopsied, and all
radiation-related toxicities have resolved

- Patients who had prior major surgery are eligible if at least 4 weeks have passed
since their surgery. All surgical wounds must have healed.

- All toxicities related to prior adjuvant therapy must have resolved.

- Written informed consent and Health Insurance Portability and Accountability Act
(HIPAA) authorization obtained from the patient prior to receipt of any study
medication or beginning study procedures

Exclusion Criteria:

- Pregnancy or nursing

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

- Current or planned participation (from day of study entry through 30 days after last
dose of MEDI-522) in a research protocol in which an investigational agent may be

- Received an investigational agent within 4 weeks prior to study entry

- Known brain metastases or primary brain tumors

- 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 T1b
prostate cancer noted incidentally during a transurethral resection of the prostate
(TURP) with prostate-specific antigen (PSA) values within normal limits since TURP,
or superficial bladder cancer

- Any evidence of or history, elicited by the investigator, of symptomatic
cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months
prior to study entry; or any history or evidence of pulmonary embolism or
thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy
(e.g., warfarin or heparin).

- Currently requiring anticoagulation (excluding use of heparin flush solutions for
maintenance of catheter lines) for any thromboembolic disease based on medical
history and physical examination

- Any current 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 immunodeficiency

- Patients with a clinical diagnosis of Acquired Immune Deficiency Syndrome (AIDS) or
known active viral hepatic infections

- A prior myocardial infarction or angina, or uncontrolled/refractory hypertension
within 6 months prior to study entry

- Any evidence of an active infection requiring parenteral anti-infective 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:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary outcome of this study is to describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.

Outcome Time Frame:

Baseline to disease progression

Safety Issue:


Principal Investigator

Stergios Moschos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

November 2007

Related Keywords:

  • Malignant Melanoma
  • Melanoma



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213