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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

Primary Purpose

Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001805
Brief Title
A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
Official Title
A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
Study Type
Interventional

2. Study Status

Record Verification Date
March 2000
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms
Keywords
Breast Cancer, Colon Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7683045
Citation
Grossbard ML, Lambert JM, Goldmacher VS, Spector NL, Kinsella J, Eliseo L, Coral F, Taylor JA, Blattler WA, Epstein CL, et al. Anti-B4-blocked ricin: a phase I trial of 7-day continuous infusion in patients with B-cell neoplasms. J Clin Oncol. 1993 Apr;11(4):726-37. doi: 10.1200/JCO.1993.11.4.726.
Results Reference
background
PubMed Identifier
8219217
Citation
Amlot PL, Stone MJ, Cunningham D, Fay J, Newman J, Collins R, May R, McCarthy M, Richardson J, Ghetie V, et al. A phase I study of an anti-CD22-deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood. 1993 Nov 1;82(9):2624-33.
Results Reference
background
PubMed Identifier
2790828
Citation
Byers VS, Rodvien R, Grant K, Durrant LG, Hudson KH, Baldwin RW, Scannon PJ. Phase I study of monoclonal antibody-ricin A chain immunotoxin XomaZyme-791 in patients with metastatic colon cancer. Cancer Res. 1989 Nov 1;49(21):6153-60.
Results Reference
background

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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

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