Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma - Full Text View

Purpose

A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.

Condition	Intervention	Phase
Melanoma	Drug: ALS-357	Phase I

MedlinePlus related topics:

Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	Dose-Escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma

Further study details as provided by Advanced Life Sciences, Inc.:

Primary Outcome Measures:

Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma. [ Time Frame: Day 8, 15, 22, 29 and 43 ] [ Designated as safety issue: Yes ]
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers. [ Time Frame: Day 8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay. [ Time Frame: Day 15, 29 and 43 ] [ Designated as safety issue: No ]
Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways. [ Time Frame: Day 15, 29 and 43 ] [ Designated as safety issue: No ]
Evaluate the plasma concentration of ALS-357 at each scheduled study visit. [ Time Frame: Day 1, 8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ALS-357 applied topically twice weekly for four weeks.	Drug: ALS-357 Topical application of ALS-357
2: Experimental ALS-357 applied topically every other day for four weeks.	Drug: ALS-357 Topical application of ALS-357
3: Experimental ALS-357 applied topically once daily for four weeks.	Drug: ALS-357 Topical application of ALS-357
4: Experimental ALS-357 applied topically twice daily for four weeks.	Drug: ALS-357 Topical application of ALS-357

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Study Participants must be 18 years or older.
Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery.
Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701987

Contacts


Contact: Timothy Kuzel, MD	312-695-1301

Locations


United States, Illinois
	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Recruiting
	Chicago, Illinois, United States, 60611
	Contact: Timothy Kuzel, MD 312-695-1301
	Principal Investigator: Timothy Kuzel, MD
	Sub-Investigator: Mario LaCouture, MD

Sponsors and Collaborators

Advanced Life Sciences, Inc.

Investigators


Principal Investigator:	Timothy Kuzel, MD	Robert H. Lurie Cancer Center

More Information

Responsible Party:	Advanced Life Sciences ( David A. Eiznhamer, Executive Vice President, Clinical Development )
Study ID Numbers:	ALS-357-001
First Received:	June 17, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00701987
Health Authority:	United States: Food and Drug Administration