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A Novel Treatment for Metastatic Melanoma

NCT ID: NCT00758797

Last Updated: 2021-12-03

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-10-31

Brief Summary

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A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.

Detailed Description

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A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser.

Conditions

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Metastatic Melanoma

Keywords

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metastatic melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Group Type EXPERIMENTAL

Photoimmunotherapy

Intervention Type OTHER

DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Interventions

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Photoimmunotherapy

DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 and older
2. Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site.
3. Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST).
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment):

Platelet count \> 40,000 per mm3 Absolute Neutrophil Count (ANC) \> 1,500 per mm3

Exclusion Criteria

1. Life expectancy, in the opinion of the investigator of less than 4 months
2. Known allergy to any drugs used in treatment
3. Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment
4. Chemotherapy/immunotherapy within 4 weeks of initiation
5. Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation
6. Radiation therapy at the treatment site within 4 weeks of initiation
7. Uncontrolled brain metastases
8. History of cutaneous photosensitization or photodermatoses
9. Non-treated, active cancers other than melanoma and non-melanoma skin cancers.
10. Active infectious disease requiring antibiotic therapy
11. Unstable medical illness
12. Past or present major psychiatric illness
13. Pregnant or lactating women
14. End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance \<50cc/min
15. Acute hepatitis (any cause)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU1213

Identifier Type: -

Identifier Source: org_study_id