Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease (NHL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00515892|
Recruitment Status : Unknown
Verified August 2007 by Cambridge Antibody Technology.
Recruitment status was: Recruiting
First Posted : August 14, 2007
Last Update Posted : August 14, 2007
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 or disease||Intervention/treatment||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 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)|
|Study Start Date :||August 2007|
- Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.
- To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515892
|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|
|Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)||Not yet recruiting|
|Contact: Krzysztof Jamroziak, MD (48) 42 689-5191|
|Principal Investigator: Tadeusz Robak, Professor|