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Sponsored by: |
Seattle Genetics, Inc. |
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Information provided by: | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier: | NCT00051597 |
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.
Condition | Intervention | Phase |
---|---|---|
Hodgkin Disease Lymphoma, Large-Cell Sarcoma, Kaposi Lymphoma, T-Cell, Cutaneous Lymphoma, B-Cell |
Drug: SGN-30 (monoclonal antibody) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Histologically confirmed CD30+ hematologic malignancy. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease.
Patients must have at least one of the following:
Patients must have at least one of the following:
EXCLUSION CRITERIA:
United States, Alabama | |
University of Alabama, Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
USC Norris Cancer Center | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Siteman Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
University of Nebraska | |
Omaha, Nebraska, United States, 68198 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
Cornell Medical College, New York Presbyterian | |
New York, New York, United States, 10021 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98109 |
Study Director: | Amy P Sing, MD | Seattle Genetics, Inc. |
Study ID Numbers: | SG030-0002 |
Study First Received: | January 13, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00051597 |
Health Authority: | United States: Food and Drug Administration |
Hodgkin's disease Hematologic Neoplasms Malignant mesenchymal tumor Hodgkin lymphoma, adult Soft tissue sarcomas Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, large-cell Neoplasms, Connective and Soft Tissue Lymphoma, T-Cell Hodgkin Disease Lymphoma Immunoglobulins Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Hematologic Diseases Sarcoma, Kaposi Recurrence Herpesviridae Infections Virus Diseases Lymphatic Diseases Antibodies B-cell lymphomas Sarcoma DNA Virus Infections Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Neoplasms, Vascular Tissue Pharmacologic Actions |