Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin) in Patients With Advanced Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00111696
First received: May 24, 2005
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

To describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.


Condition Intervention Phase
Malignant Melanoma
Biological: MEDI-522
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The primary outcome of this study is to describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma. [ Time Frame: Baseline to disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe tumor and endothelial cell viability induced by MEDI-522. [ Time Frame: Baseline and two post-therapy points after week 3 and at time of 1st disease progression ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2005
Study Completion Date: November 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-522
Drug
Biological: MEDI-522
Supplied at a concentration of 50 mg/mL in both 2 mL and 10mL vials

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 treatment
  • 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 administered
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111696

Locations
United States, Pennsylvania
University Of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Stergios Moschos, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Lawrence Danel-Moore, M.D., PhD, VP, Clin. Dev., MedImmune LLC
ClinicalTrials.gov Identifier: NCT00111696     History of Changes
Other Study ID Numbers: MI-CP121, CRRI #0305014, UPCI 05-025
Study First Received: May 24, 2005
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 28, 2014