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Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

Day 8, 15, 22, 29 and 43

Safety Issue:

Yes

Principal Investigator

Timothy Kuzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ALS-357-001

NCT ID:

NCT00701987

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Melanoma
  • Cutaneous Metastatic Melanoma
  • Melanoma

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611