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

COMPLETEDPHASE1

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

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

NCT00111696•MedImmune LLC

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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
+8 more criteria

Locations (1)

University Of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

May 1, 2005

Primary Completion Date

August 1, 2007

Completion Date

November 1, 2007

Last Updated

March 14, 2012

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

MEDI-522

BIOLOGICAL

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

View study

RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

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