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Sponsored by: |
Adherex Technologies, Inc. |
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Information provided by: | Adherex Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00421811 |
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.
Condition | Intervention | Phase |
---|---|---|
Neoplasms |
Drug: ADH-1 Drug: melphalan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-Tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007). |
Estimated Enrollment: | 56 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
University of Colorado, Denver | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
University of Florida College of Medicine | |
Gainesville, Florida, United States, 32610 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27516 | |
United States, Pennsylvania | |
Lehigh Valley Hospital | |
Allentown, Pennsylvania, United States, 18103 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Intermountain Medical Center | |
Murray, Utah, United States, 84157 |
Principal Investigator: | Doug Tyler, MD | Duke University |
Responsible Party: | Adherex Technologies, Inc. ( Clinical Study Manager ) |
Study ID Numbers: | AHX-01-007 |
Study First Received: | January 10, 2007 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00421811 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cancer tumors melanoma anticarcinogenic agents |
antineoplastic agents cadherins solid tumors |
Anticarcinogenic Agents Melphalan Immunologic Factors Antineoplastic Agents, Alkylating |
Alkylating Agents Immunosuppressive Agents Melanoma |
Anticarcinogenic Agents Melphalan Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Protective Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents |