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Home > "G" Clinical Trials Conditions > Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver  Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver
Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver
For Condition: stage 4 colon cancer,liver metastases,adenocarcinoma of the colon,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the safety and maximum tolerated dose of a single intrahepatic NV1020 injection in patients with hepatic metastases from colon cancer that has failed first-line chemotherapy. II. Determine the tolerability of this drug in these patients. III. Determine preliminarily the anti-tumor activity of this drug in these patients. IV. Assess the immunogenicity of NV1020 in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed adenocarcinoma of the colon - At least 3 metastatic hepatic lesions involving both lobes - No extrahepatic disease Failed first-line combination chemotherapy of fluorouracil plus either leucovorin calcium or irinotecan Herpes simplex virus type-1 seropositive Candidate for intrahepatic arterial infusion pump placement --Prior/Concurrent Therapy-- Biologic therapy: - At least 4 weeks since prior immunotherapy (e.g., interleukin-2, interleukin -12, or interferon) - No prior gene transfer therapy - No prior therapy with cytolytic virus of any type - No concurrent immunotherapy during and for 28 days after study therapy - No concurrent vaccines during and for 28 days after study therapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent chemotherapy during and for 28 days after study therapy Endocrine therapy: No concurrent systemic steroids during and for 28 days after study therapy Radiotherapy: - No prior radiotherapy to the liver - No concurrent radiotherapy during and for 28 days after study therapy Surgery: At least 2 weeks since prior surgery Other: - At least 30 days since prior participation in investigational study - No concurrent antiviral agent active against herpes simplex virus (e.g., acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, or cidofovir) during and for 28 days after study therapy - No concurrent immunosuppressive agents (e.g., cyclosporine) during and for 28 days after study therapy - No other concurrent investigational or anti-cancer agents during and for 28 days after study therapy --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: - WBC greater than 3,000/mm3 - Absolute neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin greater than 9.0 g/dL - No history of any blood clotting disorder (e.g., hemophilia) Hepatic: - Transaminases no greater than 3 times upper limit of normal - Bilirubin no greater than 2.0 mg/dL - No active hepatitis - No history of hepatic fibrosis, cirrhosis, or hemochromatosis Renal: Creatinine no greater than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - All patients must use effective barrier contraception during and for at least 6 months after study - HIV negative - No active herpes infection - No other active uncontrolled infection - No prior weight loss of more than 10 lbs within the past month - No history of alcohol or other substance abuse - No concurrent unstable and/or severe medical or psychological condition - No history of any other medical or psychological condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
YumanFong, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068488; MGENE-NR1-001,NCI-G01-1920,MSKCC-00022
Study Start Date: October 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012155
Other Liver Metastases Studies:
1. Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
2. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
3. Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
4. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
Related Studies:
Other liver metastases Clinical Trials
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Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver
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