A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
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|ClinicalTrials.gov Identifier: NCT00001805|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
|First Submitted Date ICMJE||November 3, 1999|
|First Posted Date ICMJE||December 10, 2002|
|Last Update Posted Date||March 4, 2008|
|Study Start Date ICMJE||March 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001805 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab|
|Official Title ICMJE||A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab|
|Brief Summary||This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.|
|Detailed Description||This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Rituximab|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||June 2000|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must have advanced stage solid tumor with histologically or cytologically proven evaluable or measurable disease and who are refractory to standard treatment for their malignancy or for whom no effective standard therapy exists.
Must have the presence of B3 antigen on the surface of greater than 30% of the tumor cells.
Must be greater than or equal to 18 years old and be able to give informed consent.
Must have an ECOG performance status of 0 or 1 and a minimum life expectancy of 3 months.
Must have normal renal function (Creatinine less than or equal to 1.4 mg/dl), SGOT and SGPT less than or equal to 2.5 x of the upper limits of normal. Total bilirubin less than 1.5 mg/dL; AGC greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).
Must have recovered from the toxic effects of prior chemotherapy or radiation therapy. At least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. At least six weeks must have elapsed since the last dose of Mitomycin C and a nitrosourea.
Must not have serum neutralizing antibodies to LMB-1.
Must not have positive hepatitis B surface antigen, hepatitis C antibody or HIV.
Must not have a history of coronary artery disease, NY class II-IV CHF, arrhythmia requiring treatment and any contraindication to pressor therapy.
Must not have FEV1 and FVC less than or equal to 65% of the predicted value.
Must not have baseline serum albumin of less than 3.0 g/dl.
Must not have a history of CNS metastasis and/or known seizure disorders, or concurrent malignancy.
Must not have an acute bacterial infection that requires antibiotic therapy (unless infection is completely resolved).
Must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Must not be pregnant or breastfeeding. Patients of childbearing potential must agree to use an effective method of contraception.
Must not have a history of allergic reaction to penicillin.
Must not have lymphoma.
|Ages||Child, Adult, Older Adult|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001805|
|Other Study ID Numbers ICMJE||990071
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP