LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
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.
Checked against the public recordLast updated Nov 4, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Maryland, Baltimore
- Interventions being studied
- Biological: LMB-9 immunotoxin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 4, 2019. Always confirm current availability with the study team.