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| Sponsor: | Seattle Genetics, Inc. |
|---|---|
| Information provided by: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00051597 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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. |
More Information
| Study ID Numbers: | SG030-0002 |
| Study First Received: | January 13, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00051597 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Immunologic Factors Hematologic Neoplasms Physiological Effects of Drugs Lymphoma, B-Cell Antibodies, Monoclonal Neoplasms, Connective and Soft Tissue Neoplasms by Site Lymphoma, T-Cell Neoplasms, Vascular Tissue Lymphoma Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Sarcoma, Kaposi Pharmacologic Actions Herpesviridae Infections Virus Diseases Lymphatic Diseases Neoplasms Antibodies Sarcoma DNA Virus Infections Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous |