A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
This study has been completed.
Sponsor:
Adherex Technologies, Inc.
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00421811
First received: January 10, 2007
Last updated: December 27, 2010
Last verified: December 2010
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Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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). |
Resource links provided by NLM:
Further study details as provided by Adherex Technologies, Inc.:
Primary Outcome Measures:
- To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions [ Time Frame: By Week 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | April 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: ADH-1
4 gm IV Days 1 and 8
Drug: melphalan
By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed written informed consent
- Male and female patients > or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate
- Measurable disease
- Disease site(s) must be distal to the planned site of tourniquet placement
- Available for immunohistochemical testing of N-cadherin expression tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG
Exclusion Criteria:
- Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay)
- Stage IV melanoma
- Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
- History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
- Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
- Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities
- Allergic reaction to any therapeutic peptide or to melphalan
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421811
Locations
| United States, Colorado | |
| University of Colorado, Denver | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| University of Florida College of Medicine | |
| Gainesville, Florida, United States, 32610 | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| 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 | |
Sponsors and Collaborators
Adherex Technologies, Inc.
Investigators
| Principal Investigator: | Doug Tyler, MD | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Clinical Study Manager, Adherex Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00421811 History of Changes |
| Other Study ID Numbers: | AHX-01-007 |
| Study First Received: | January 10, 2007 |
| Last Updated: | December 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Adherex Technologies, Inc.:
|
cancer tumors melanoma anticarcinogenic agents |
antineoplastic agents cadherins solid tumors |
Additional relevant MeSH terms:
|
Neoplasms Antineoplastic Agents Melphalan Anticarcinogenic Agents Therapeutic Uses Pharmacologic Actions Myeloablative Agonists |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013