Recruiting
Phase 1

ALS-357

Sponsor:

Advanced Life Sciences, Inc.

Code:

NCT00701987

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ALS-357

Study Details

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.

Conditions

Melanoma

Study ID

NCT00701987

Start date

Jun, 2008

Status verified date

Feb, 2010

Primary completion date

Jun, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

ALS-357 applied topically twice weekly for four weeks.

experimental: 2

ALS-357 applied topically every other day for four weeks.

experimental: 3

ALS-357 applied topically once daily for four weeks.

experimental: 4

ALS-357 applied topically twice daily for four weeks.

Interventions

ALS-357

Topical application of ALS-357

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Timothy Kuzel, MD

312-695-1301

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Timothy Kuzel, MD

312-695-1301

Principal Investigator:

Timothy Kuzel, MD

More Information

Sponsor

Advanced Life Sciences, Inc.

Last update posted

Feb 3, 2010

Last verified

Feb, 2010

Keywords

  • Cutaneous Metastatic Melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Advanced Life Sciences, Inc. on 2010-02-03.