Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Advanced Life Sciences, Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Advanced Life Sciences, Inc.
Information provided by:
Advanced Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00701987
First received: June 17, 2008
Last updated: February 2, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: ALS-357 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Advanced Life Sciences, Inc.:
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. [ Time Frame: Day 8, 15, 22, 29 and 43 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay. [ Time Frame: Day 15, 29 and 43 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Evaluate the plasma concentration of ALS-357 at each scheduled study visit. [ Time Frame: Day 1, 8, 15, 22, 29 and 43 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ALS-357 applied topically twice weekly for four weeks.
|
Drug: ALS-357
Topical application of ALS-357
|
|
Experimental: 2
ALS-357 applied topically every other day for four weeks.
|
Drug: ALS-357
Topical application of ALS-357
|
|
Experimental: 3
ALS-357 applied topically once daily for four weeks.
|
Drug: ALS-357
Topical application of ALS-357
|
|
Experimental: 4
ALS-357 applied topically twice daily for four weeks.
|
Drug: ALS-357
Topical application of ALS-357
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701987
Contacts
| Contact: Timothy Kuzel, MD | 312-695-1301 |
Locations
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Timothy Kuzel, MD 312-695-1301 | |
| Principal Investigator: Timothy Kuzel, MD | |
| Sub-Investigator: Mario LaCouture, MD | |
Sponsors and Collaborators
Advanced Life Sciences, Inc.
Investigators
| Principal Investigator: | Timothy Kuzel, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | David A. Eiznhamer, Executive Vice President, Clinical Development, Advanced Life Sciences |
| ClinicalTrials.gov Identifier: | NCT00701987 History of Changes |
| Other Study ID Numbers: | ALS-357-001 |
| Study First Received: | June 17, 2008 |
| Last Updated: | February 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Advanced Life Sciences, Inc.:
|
Cutaneous Metastatic Melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 16, 2013