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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072098 |
RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Metastatic Cancer |
Drug: adenovirus vector Drug: interleukin-12 gene |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver |
Estimated Enrollment: | 36 |
Study Start Date: | September 2003 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive ultrasound-guided intratumoral injections of adenoviral vector-delivered interleukin-12 gene (ADV-hIL12) on day 1.
Cohorts of 3-6 patients receive escalating doses of ADV-hIL12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at days 11, 15, 29, 43, and 57 and are then followed for survival thereafter.
PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed* colorectal adenocarcinoma metastatic to the liver
Solitary or multiple metastatic tumors in the liver
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Mount Sinai Medical Center | Recruiting |
New York, New York, United States, 10029 | |
Contact: Max W. Sung, MD 212-241-7902 max.sung@mssm.edu |
Principal Investigator: | Max W. Sung, MD | Mount Sinai School of Medicine |
Study ID Numbers: | CDR0000335463, MTS-GCO-975642, MTS-GCO-971592 |
Study First Received: | November 4, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00072098 |
Health Authority: | Unspecified |
stage IV colon cancer stage IV rectal cancer liver metastases recurrent rectal cancer recurrent colon cancer |
Interleukin-12 Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |