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Home > "S" Clinical Trials Conditions > Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients with Limited Residual Disease After Surgery  Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients with Limited Residual Disease After Surgery
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients with Limited Residual Disease After Surgery
For Condition: Colorectal Neoplasms
Status: Terminated
Sponsor(s): Immunomedics, Inc. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 /= 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.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
TerenceRugg, Study Director, Immunomedics, Inc.
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Additional Information:
Study ID Numbers: IM-T-hMN14-06;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041691
Other Colorectal Neoplasms Studies:
1. Tezacitabine and oxaliplatin for the treatment of patients with metastatic colorectal cancer
2. A multicenter phase 2 study of CI-1040 in patients with advanced nonsmall-cell lung cancer, breast cancer, colon cancer, or pancreatic cancer
3. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
4. An Open Label Study of a Peptide Vaccine in Patients with Stage III Colon Cancer
5. Colorectal Cancer
Related Studies:
Other Colorectal Neoplasms Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients with Limited Residual Disease After Surgery
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