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A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms

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Trial Information

A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

990071

NCT ID:

NCT00001805

Start Date:

March 1999

Completion Date:

June 2000

Related Keywords:

  • Breast Neoplasms
  • Colonic Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Stomach Neoplasms
  • Breast Cancer
  • Colon Cancer
  • Gastric Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Breast Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892