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
Sponsor:
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
  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 April 14, 2014