Spots Global Cancer Trial Database for A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
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Trial Identification
Brief Title: A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
Official Title: A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
Study ID: NCT00051597
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies. This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Birmingham, Alabama, United States
USC Norris Cancer Center, Los Angeles, California, United States
University of Miami, Miami, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Siteman Cancer Center, St. Louis, Missouri, United States
University of Nebraska, Omaha, Nebraska, United States
Cornell Medical College, New York Presbyterian, New York, New York, United States
University of Rochester, Rochester, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Washington, Seattle, Washington, United States
Contact Details
Name: Amy P Sing, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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