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

Primary Purpose

Melanoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALS-357
Sponsored by
Advanced Life Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Cutaneous Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

ALS-357 applied topically twice weekly for four weeks.

ALS-357 applied topically every other day for four weeks.

ALS-357 applied topically once daily for four weeks.

ALS-357 applied topically twice daily for four weeks.

Outcomes

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.
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.

Secondary Outcome Measures

Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
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.
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.

Full Information

First Posted
June 17, 2008
Last Updated
February 2, 2010
Sponsor
Advanced Life Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00701987
Brief Title
Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Advanced Life Sciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Cutaneous Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ALS-357 applied topically twice weekly for four weeks.
Arm Title
2
Arm Type
Experimental
Arm Description
ALS-357 applied topically every other day for four weeks.
Arm Title
3
Arm Type
Experimental
Arm Description
ALS-357 applied topically once daily for four weeks.
Arm Title
4
Arm Type
Experimental
Arm Description
ALS-357 applied topically twice daily for four weeks.
Intervention Type
Drug
Intervention Name(s)
ALS-357
Intervention Description
Topical application of ALS-357
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
Time Frame
Day 15, 29 and 43
Title
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
Title
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
Time Frame
Day 1, 8, 15, 22, 29 and 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Kuzel, MD
Phone
312-695-1301
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Kuzel, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Kuzel, MD
Phone
312-695-1301
First Name & Middle Initial & Last Name & Degree
Timothy Kuzel, MD
First Name & Middle Initial & Last Name & Degree
Mario LaCouture, MD

12. IPD Sharing Statement

Learn more about this trial

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

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