A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

Phase 1

Completed

• Conditions: Hodgkin Disease; Lymphoma, Large-Cell; Sarcoma, Kaposi; Lymphoma, T-Cell, Cutaneous; Lymphoma, B-Cell

• Registration Number: NCT00051597
• Lead Sponsor: Seagen Inc.

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

Not available

Study Timeline

• Study First Submitted: 2003-01-13
• Study First Submitted QC: 2003-01-14
• Study First Posted: 2003-01-15
• Study Completion: 2003-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (10)

University of Rochester; 🇺🇸 Rochester, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Nebraska; 🇺🇸 Omaha, Nebraska, United States

Cornell Medical College, New York Presbyterian; 🇺🇸 New York, New York, United States

USC Norris Cancer Center; 🇺🇸 Los Angeles, California, United States

Siteman Cancer Center; 🇺🇸 St. Louis, Missouri, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States