A Novel Treatment for Metastatic Melanoma

NCT00758797 | Terminated Phase 1 DMC

• 1 other identifier: STU1213
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Melanoma

Keywords

metastatic melanoma

Outcome Measures

Primary Outcomes (1)

• Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.

  24 weeks

Secondary Outcomes (3)

• Assess time to disease progression

  24 weeks to years

• Evaluate tumor response by measuring clinically apparent tumors throughout study.

  24 weeks

• Quantify overall survival in this study population

  years

Study Arms (1)

1

EXPERIMENTAL

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

Other: Photoimmunotherapy

Interventions

Photoimmunotherapy OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older
• Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site.
• Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: September 25, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

US (1)