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LMB-9 Immunotoxin in Treating Patients With Advanced Solid Tumors

Primary Purpose

Bladder Cancer, Breast Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LMB-9 immunotoxin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, recurrent colon cancer, stage IV esophageal cancer, recurrent esophageal cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV non-small cell lung cancer, stage IV pancreatic cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor refractory to standard treatment or for which no effective standard therapy exists Bladder cancer Breast cancer Colon cancer Esophageal cancer Gastric cancer Non-small cell lung cancer Pancreatic cancer Evaluable or measurable disease B3 antigen present on more than 30% of tumor cells No prior or concurrent CNS metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT less than 5 times upper limit of normal Albumin at least 3.0 g/dL No history of liver disease No positive hepatitis B or C antigen Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No history of coronary artery disease No New York Association class II-IV heart disease No arrhythmia requiring treatment No contraindications to pressor therapy Pulmonary: FEV1 and FVC greater than 65% of predicted value Pulmonary function test required of patients with significant smoking history or possible pulmonary disease Other: No active peptic ulcer disease No known allergy to omeprazole No history of seizure disorders No other concurrent malignancy No concurrent medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosourea) and recovered Endocrine therapy: At least 3 weeks since prior hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

Sites / Locations

  • Medicine Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019435
Brief Title
LMB-9 Immunotoxin in Treating Patients With Advanced Solid Tumors
Official Title
Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas That Express Lewis Y Antigen
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: The LMB-9 immunotoxin may be able to locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced solid tumors. PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced solid tumors that have not responded to standard therapy.
Detailed Description
OBJECTIVES: I. Determine the toxic effects and the pharmacokinetics of LMB-9 immunotoxin in patients with advanced solid tumors that express Lewis Y antigen. II. Evaluate the anti-tumor activity and the immunogenicity of this treatment regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients with negative neutralizing antibody to LMB-9 immunotoxin with stable or responding disease receive additional courses every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients may be treated at the MTD. Patients are followed at 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued within 12-24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Breast Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer
Keywords
stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, recurrent colon cancer, stage IV esophageal cancer, recurrent esophageal cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV non-small cell lung cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
LMB-9 immunotoxin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor refractory to standard treatment or for which no effective standard therapy exists Bladder cancer Breast cancer Colon cancer Esophageal cancer Gastric cancer Non-small cell lung cancer Pancreatic cancer Evaluable or measurable disease B3 antigen present on more than 30% of tumor cells No prior or concurrent CNS metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT less than 5 times upper limit of normal Albumin at least 3.0 g/dL No history of liver disease No positive hepatitis B or C antigen Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No history of coronary artery disease No New York Association class II-IV heart disease No arrhythmia requiring treatment No contraindications to pressor therapy Pulmonary: FEV1 and FVC greater than 65% of predicted value Pulmonary function test required of patients with significant smoking history or possible pulmonary disease Other: No active peptic ulcer disease No known allergy to omeprazole No history of seizure disorders No other concurrent malignancy No concurrent medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosourea) and recovered Endocrine therapy: At least 3 weeks since prior hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Pastan, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Medicine Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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LMB-9 Immunotoxin in Treating Patients With Advanced Solid Tumors

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