Status:
COMPLETED
Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors
Lead Sponsor:
ImmunoGen, Inc.
Conditions:
Non-colorectal Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242, can block tumor growth in different ways. Some block the ability of tumor cells to grow and ...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic co...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00352131
Start Date
February 1 2005
End Date
December 1 2009
Last Update
March 17 2010
Active Locations (2)
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1
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
2
UT Health Science Center
San Antonio, Texas, United States, 78245-3217