Breast Cancer Clinical Trial
Official title:
Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion
Verified date | October 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced colon, breast, non-small cell lung, bladder, pancreatic, or ovarian cancer. The LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2003 |
Est. primary completion date | December 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced colon, breast, non-small cell lung, bladder, pancreas, or ovarian cancer refractory to standard treatment or for which no effective standard therapy exists - Expresses Lewis Y antigen - Evidence of disease progression - B3 antigen on the surface of more than 30% of the tumor cells determined by immunohistochemistry - No neutralizing antibodies to LMB-9 immunotoxin - No untreated CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Performance status: - ECOG 0-1 Life expectancy: - At least 3 months Hematopoietic: - Absolute granulocyte count greater than 1,200/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT and SGPT no greater than 2.5 times upper limit of normal (liver metastases allowed) - Albumin at least 3.0 g/dL - No prior liver disease (e.g., alcohol liver disease) - Hepatitis B and C negative Renal: - Creatinine no greater than 1.4 mg/dL - Creatinine clearance greater than 60 mL/min - Proteinuria less than 1 g/24 hours Cardiovascular: - No history of coronary artery disease - No cardiac arrhythmia requiring therapy - No New York Heart Association class II-IV congestive heart failure Pulmonary: - Pulmonary function test required if significant smoking history, possible pulmonary disease, or lung cancer - FEV1 and FVC at least 65% predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known seizure disorders - No urinary tract infection - No other concurrent malignancy - No active peptic ulcer disease - No known allergy to omeprazole - No contraindication to pressor therapy - No other concurrent medical or psychological condition that would preclude study PRIOR CONCURRENT THERAPY: Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: - At least 3 weeks since prior hormonal therapy Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered |
Country | Name | City | State |
---|---|---|---|
United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | National Cancer Institute (NCI) |
United States,
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