Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors
Non-colorectal Cancer, Pancreatic Cancer
About this trial
This is an interventional treatment trial for Non-colorectal Cancer focused on measuring unspecified adult solid tumor, protocol specific, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor Inoperable or metastatic disease Failed standard therapy Confirmed cancer antigen (CanAg) expression Patients must have non-colorectal cancer or pancreatic cancer Tumor must have a homogeneous pattern (i.e., staining present in > 75% of tumor cells for CanAg) and are 2+ or 3+ intensity by immunohistochemistry * No known leptomeningeal disease or progressive brain disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm³ Hemoglobin ≥ 9 g/dL (transfusion allowed) Platelet count ≥ 100,000/mm³ aPTT and INR ≤ 1.5 times upper limit of normal (ULN) Creatinine ≤ 1.5 mg/dL Creatinine clearance ≥ 60 mL/min Bilirubin ≤ 1.5 mg/dL AST and ALT < 2.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 30 days after completion of study treatment No hypersensitivity to agents of the same class as the study drug, humanized or nonhumanized antibodies, or immunoconjugates No active, uncontrolled infection No hepatitis B surface antigen or hepatitis C antibody positivity No history of alcoholic liver disease No serious medical or psychiatric disorder that would preclude compliance with study requirements No peripheral neuropathy > grade 1 No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer No severe concurrent disease or condition that, in the opinion of the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: Recovered from prior therapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) At least 4 weeks since prior radiotherapy, immunotherapy, or hormone therapy for cancer At least 4 weeks since prior major surgery No concurrent chemotherapy, other immunotherapy, radiotherapy, or other investigational therapy Palliative radiotherapy for related bone metastases allowed No other concurrent anticancer therapy
Sites / Locations
- South Texas Accelerated Research Therapeutics
- UT Health Science Center