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A Novel Treatment for Metastatic Melanoma

This study has been terminated.
(Study was not renewed during annual Northwestern Cancer Center review.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758797
First Posted: September 25, 2008
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
June 23, 2008
September 25, 2008
May 23, 2014
April 2008
October 2012   (Final data collection date for primary outcome measure)
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events. [ Time Frame: 24 weeks ]
  • Tolerability of novel treatment through evaluation of subject response and physician observation of adverse events. [ Time Frame: 24 weeks ]
  • Evaluation of disease status using the RECIST criteria. [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00758797 on ClinicalTrials.gov Archive Site
  • Assess time to disease progression [ Time Frame: 24 weeks to years ]
  • Evaluate tumor response by measuring clinically apparent tumors throughout study. [ Time Frame: 24 weeks ]
  • Quantify overall survival in this study population [ Time Frame: years ]
  • establish overall disease response [ Time Frame: 24 weeks ]
  • long-term recurrence rate [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
A Novel Treatment for Metastatic Melanoma
In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Melanoma
Other: Photoimmunotherapy
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
Experimental: 1
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
Intervention: Other: Photoimmunotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
October 2012
October 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00758797
STU1213
Yes
Not Provided
Not Provided
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP