Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoGen, Inc.

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