Colorectal Neoplasms
Conditions
Keywords
Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumor
Brief summary
The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Disease Characteristics: * Patients with documented histologic and cytologic diagnosis of colon or rectal malignancy * Patients with documented status post surgical resection of primary cancer or metastases * Limited residual disease (i.e., CEA serum levels \< 15 ng/mL and negative baseline CT scans, or no lesion \> 1 cm) Prior/Concurrent Therapy: * Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy, other investigational therapy for cancer, or surgical procedures at least six weeks prior to study entry. * Patients must have recuperated from surgery and toxicities (as a result of previous therapy) sufficiently prior to study entry * Biologic Therapy: Patients who have received a murine, chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA) * Radiotherapy: No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys) Patient Characteristics/Inclusion Criteria: * Performance Status: Patients with Karnofsky performance status \> 70% * Hematopoietic: ANC \>/= 1.5 x 10/L; Hemoglobin \>/= 10 g/dL; Platelets \>/= 100 x 10/L * Renal: Serum Creatinine \</= 1.5 x ULN * Hepatic: Serum Bilirubin \</= 1.5 ULN; AST and ALT \</= 2.5 x ULN; Alk Phosphatase \</= 2.5 x ULN * Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO tests * Pulmonary: Patients with DF and FEV1 \>/= 60% by required Pulmonary Function Tests * Central Nervous System: Patients with known metastatic disease to the CNS are excluded. * Other: Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.
Countries
United States