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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 below
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I have two areas of skin cancer spread that can't be surgically removed.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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.

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.

Find a Location

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

ALS-357 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00701987 — Phase 1
Melanoma Research Study Groups: 1, 4, 2, 3
Melanoma Clinical Trial 2023: ALS-357 Highlights & Side Effects. Trial Name: NCT00701987 — Phase 1
ALS-357 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00701987 — Phase 1
~1 spots leftby Jan 2026
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