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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00701987
• Other study ID #: ALS-357-001
• Status: Recruiting
• Phase: Phase 1
• First received: June 17, 2008
• Last updated: February 2, 2010
• Start date: June 2008

Study information

• Verified date: February 2010
• Source: Advanced Life Sciences, Inc.
• Contact: Timothy Kuzel, MD
• Phone: 312-695-1301
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• ALS-357
Topical application of ALS-357

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 8, 15, 22, 29 and 43	Yes
Primary	Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.		Day 8, 15, 22, 29 and 43	No
Secondary	Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.		Day 15, 29 and 43	No
Secondary	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.		Day 15, 29 and 43	No
Secondary	Evaluate the plasma concentration of ALS-357 at each scheduled study visit.		Day 1, 8, 15, 22, 29 and 43	No