LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder,… (NCT00005858) | Clinical Trial Compass
CompletedPhase 1
LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
United States25 participantsStarted 2000-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …