Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Cambridge Antibody Technology |
---|---|
Information provided by: | Cambridge Antibody Technology |
ClinicalTrials.gov Identifier: | NCT00515892 |
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy.
PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment.
Condition | Intervention | Phase |
---|---|---|
Leukemia Non-Hodgkin's Lymphoma NHL |
Drug: Immunotoxin therapy Drug: CAT-8015 Immunotoxin Procedure: Biological therapy Procedure: Antibody Therapy Procedure: Monoclonal Antibody Therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL) |
Estimated Enrollment: | 50 |
Study Start Date: | August 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS:
Evidence of CD22-positive malignancy by the following criteria,
PATIENTS CHARACTERISTICS
Performance Status
Life Expectancy
Other
Exclusion Criteria:
Hepatic function: serum transaminases (either ALT or AST) or bilirubin
Renal function: Serum creatinine clearance ≤ 60mL/min as estimated by Cockroft-Gault formula
Hematologic function:
Pulmonary function:
Recent prior therapy:
United States, California | |
Tower Hematology Oncology Medical Group | Recruiting |
Beverly Hills, California, United States, 90211 | |
Contact: Marie Fuerst, RN, MS 310-285-7269 | |
Principal Investigator: Peter Rosen, MD | |
United States, Maryland | |
Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: NCI Clinical Trials Referral Office 888-624-1937 | |
Principal Investigator: Robert J Kreitman, MD | |
Poland | |
Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz) | Not yet recruiting |
Lodz, Poland | |
Contact: Krzysztof Jamroziak, MD (48) 42 689-5191 | |
Principal Investigator: Tadeusz Robak, Professor |
Study ID Numbers: | CAT-8015-1003 |
Study First Received: | August 10, 2007 |
Last Updated: | August 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00515892 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Lymphatic Diseases Leukemia Antibodies Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunotoxins Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |