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

February 2, 2010 updated by: Advanced Life Sciences, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ALS-357 applied topically twice weekly for four weeks.
Drug: ALS-357
Topical application of ALS-357
Experimental: 2
ALS-357 applied topically every other day for four weeks.
Drug: ALS-357
Topical application of ALS-357
Experimental: 3
ALS-357 applied topically once daily for four weeks.
Drug: ALS-357
Topical application of ALS-357
Experimental: 4
ALS-357 applied topically twice daily for four weeks.
Drug: ALS-357
Topical application of ALS-357

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 8, 15, 22, 29 and 43
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
Day 8, 15, 22, 29 and 43

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
Time Frame: Day 15, 29 and 43
Day 15, 29 and 43
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
Day 15, 29 and 43
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
Time Frame: Day 1, 8, 15, 22, 29 and 43
Day 1, 8, 15, 22, 29 and 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Life Sciences, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS-357-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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