Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedFebruary 3, 2010
February 1, 2010
1 year
June 17, 2008
February 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (3)
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
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.
Day 15, 29 and 43
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
Day 1, 8, 15, 22, 29 and 43
Study Arms (4)
1
EXPERIMENTALALS-357 applied topically twice weekly for four weeks.
2
EXPERIMENTALALS-357 applied topically every other day for four weeks.
3
EXPERIMENTALALS-357 applied topically once daily for four weeks.
4
EXPERIMENTALALS-357 applied topically twice daily for four weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Kuzel, MD
Robert H. Lurie Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Last Updated
February 3, 2010
Record last verified: 2010-02