Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma

NCT ID: NCT00701987

Last Updated: 2010-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

ALS-357 applied topically twice weekly for four weeks.

Group Type EXPERIMENTAL

ALS-357

Intervention Type DRUG

Topical application of ALS-357

2

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

Group Type EXPERIMENTAL

ALS-357

Intervention Type DRUG

Topical application of ALS-357

3

ALS-357 applied topically once daily for four weeks.

Group Type EXPERIMENTAL

ALS-357

Intervention Type DRUG

Topical application of ALS-357

4

ALS-357 applied topically twice daily for four weeks.

Group Type EXPERIMENTAL

ALS-357

Intervention Type DRUG

Topical application of ALS-357

Interventions

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ALS-357

Topical application of ALS-357

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Life Sciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Advanced Life Sciences

Principal Investigators

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Timothy Kuzel, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

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Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timothy Kuzel, MD

Role: CONTACT

312-695-1301

Facility Contacts

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Timothy Kuzel, MD

Role: primary

312-695-1301

Other Identifiers

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ALS-357-001

Identifier Type: -

Identifier Source: org_study_id

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