Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
Phase 1
- Conditions
- Melanoma
- Interventions
- Drug: ALS-357
- Registration Number
- NCT00701987
- Lead Sponsor
- Advanced Life Sciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ALS-357 ALS-357 applied topically twice weekly for four weeks. 2 ALS-357 ALS-357 applied topically every other day for four weeks. 3 ALS-357 ALS-357 applied topically once daily for four weeks. 4 ALS-357 ALS-357 applied topically twice daily for four weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States