Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors (NCT00066651) | Clinical Trial Compass
CompletedPhase 1
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
United StatesStarted 2003-07
Plain-language summary
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors.
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 confirmed advanced malignancy of 1 of the following types:
* Ovarian cancer
* All nonmucinous epithelial histologies are eligible
* Primary peritoneal cavity cancer
* Fallopian tube cancer
* Malignant mesothelioma
* No sarcomatous histology
* Pancreatic cancer
* Squamous cell cancer (SCC) of the lung
* SCC of the cervix
* SCC of the head and neck
* Recurrent unresectable disease, meeting 1 of the following criteria:
* Previously treated with definitive standard therapy
* Patient refused prior standard therapy
* Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry\* NOTE: \*Immunohistochemical evaluation not required for patients with pancreatic cancer
* Measurable or evaluable disease
* No clinically significant pericardial effusion
* No known CNS or spinal cord involvement by tumor
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN
* Albumin at least 3.0 g/dL
* Hepatitis B and C negative
* Seropositive allowed if clinically asymptomatic
* except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria
Renal
* Creatinine no greater than ULN
* Cal…