A Novel Treatment for Metastatic Melanoma

This study has been terminated.
(Study was not renewed during annual Northwestern Cancer Center review.)
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00758797
First received: June 23, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Metastatic Melanoma
Other: Photoimmunotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess time to disease progression [ Time Frame: 24 weeks to years ] [ Designated as safety issue: No ]
  • Evaluate tumor response by measuring clinically apparent tumors throughout study. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quantify overall survival in this study population [ Time Frame: years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: April 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
Other: Photoimmunotherapy
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758797

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00758797     History of Changes
Other Study ID Numbers: STU1213
Study First Received: June 23, 2008
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014