A Phase 1 interventional study of NV1020 in Colorectal Cancer and Metastatic Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy.
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the aid of hepatic arteriography.
Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.
Patients are followed at 1, 2, and 3 months post injection. Patients may participate in a separate long term (up to 1 year) follow-up study for continued assessment and monitoring.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
Browse Neoplasm Metastasis studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Nov 2002. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center