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Topical Ointment for Melanoma
Phase 1
Waitlist Available
Led By Timothy Kuzel, MD
Research Sponsored by Advanced Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have 2 sites of cutaneous metastatic melanoma that cannot be removed with surgery
Participants must be 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 8, 15, 22, 29 and 43
Awards & highlights
Study Summary
This trial is testing a new topical ointment to treat melanoma. The ointment will be applied for four weeks in increasing doses to see how well it works and if it has any side effects.
Who is the study for?
This trial is for adults with cutaneous metastatic melanoma that can't be surgically removed. They may have had chemo or immunotherapy, but not within the last 4 weeks before starting this study.Check my eligibility
What is being tested?
The trial is testing ALS-357 as a topical ointment on patients with skin-related spread of melanoma. It's to see how safe it is and if it works when given in increasing doses over four weeks.See study design
What are the potential side effects?
Since this is an early-phase trial, specific side effects of ALS-357 are being studied. However, potential side effects might include skin irritation at the application site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have two areas of skin cancer spread that can't be surgically removed.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 8, 15, 22, 29 and 43
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 8, 15, 22, 29 and 43
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
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.
Secondary outcome measures
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
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.
Trial Design
4Treatment groups
Experimental Treatment
Group I: 4Experimental Treatment1 Intervention
ALS-357 applied topically twice daily for four weeks.
Group II: 3Experimental Treatment1 Intervention
ALS-357 applied topically once daily for four weeks.
Group III: 2Experimental Treatment1 Intervention
ALS-357 applied topically every other day for four weeks.
Group IV: 1Experimental Treatment1 Intervention
ALS-357 applied topically twice weekly for four weeks.
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Who is running the clinical trial?
Advanced Life Sciences, Inc.Lead Sponsor
2 Previous Clinical Trials
1,106 Total Patients Enrolled
Timothy Kuzel, MDPrincipal InvestigatorRobert H. Lurie Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have two areas of skin cancer spread that can't be surgically removed.I haven't had chemotherapy or immunotherapy in the last 4 weeks.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 4
- Group 3: 2
- Group 4: 3
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a new or existing study?
"Currently, there is only one ongoing trial for ALS-357. This global study first began in 2008 and, after completion of its Phase 1 approval stage, has seen 3 additional trials. The sponsor for this research is Advanced Life Sciences, Inc. and, to date, a total of 12 individuals have participated."
Answered by AI
Is there a potential for serious side effects with ALS-357?
"The current understanding of ALS-357 suggests that it is safe for use in humans, but this is based on limited data from phase 1 trials."
Answered by AI
Are there any other ongoing research projects studying the effects of ALS-357?
"There is currently a single, active clinical trial for ALS-357. As this is a phase 0 study, there has not been extensive testing for safety or efficacy yet. Most of the research is being conducted in Chicago, but there is at least one other location running studies."
Answered by AI
Are there any unfilled roles in this ongoing research project?
"No, this trial is not currently looking for participants. Although the trial's last update was on February 2nd, 2010, there are 781 other studies that are currently recruiting."
Answered by AI
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