Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease (NHL)
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.
Drug: Immunotoxin therapy
Drug: CAT-8015 Immunotoxin
Procedure: Biological therapy
Procedure: Antibody Therapy
Procedure: Monoclonal Antibody Therapy
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)|
- 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.
|Study Start Date:||August 2007|
Please refer to this study by its ClinicalTrials.gov identifier: 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|