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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 4, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.