Wednesday, January 31, 2007

Adherex Phase 1 Clinical Trial for testing MELANOMA treatment coming soon

This announced plan for a clinical trial of Adherex's ADH-1 to be combo therapy tested for dose tolerance effects against MELANOMA tumors is where ADH-1 will begin its hoped for journey to successes against difficult cancer tumor types, with the hoped for promise seen in preclinical testing of combo cancer treatments using ADH-1 and the conventional chemo for the specific tumor.

Apparently there were hints of success in preclinical tests of this same treatment to be tested in this P1 clinical trial, generating unsual tumor regression in the almost impossible to treat Melanoma.

[this was presented in the last quarter's conference call online presentation foils - where the slides included preliminary information on the preclinical testing of combo ADH-1 ?Mephalan for melanoma... to clarify this was indeed public info, albeit a bit obtuse in references in the slides, and later questions in the CC]

Godspeed Dr. Peters ... and best of luck to the patients, as you are in most capable hands.
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From http://clinicaltrials.gov/ct/show/NCT00421811?order=4
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A Phase 1 Dose Escalation Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan

This study is not yet open for patient recruitment.
Verified by Adherex Technologies, Inc. January 2007
Sponsored by: Adherex Technologies, Inc.
Information provided by: Adherex Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00421811

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 I

MedlinePlus related topics: Cancer
Genetics Home Reference related topics: Cancer

Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment

Official Title: An Open-Label, Multicenter, Phase 1 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).

Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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)
* 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

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00421811

North Carolina
Duke University Medical Center, Durham, North Carolina, 27516, United States
Gretchen Mann, RN, BSN 919-684-6858 gretchen.mann.sanders@duke.edu
Doug Tyler, MD, Principal Investigator

Study chairs or principal investigators
Doug Tyler, MD, Principal Investigator, Duke University

More Information
Study ID Numbers: AHX-01-007 Last Updated: January 10, 2007
Record first received: January 10, 2007
ClinicalTrials.gov Identifier: NCT00421811
Health Authority: United States: Food and Drug Administration
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[ed - more of my prior Adherex posts are linked just below]

adherex-receives-regulatory-approval-for-dosing-increase

article-on-genesis-of-adherex

cadherins-and-looming-revolution-in-cancer-treatment





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