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A Novel Treatment for Metastatic Melanoma

Sponsor
Northwestern University (Other)
Overall Status
Terminated
CT.gov ID
NCT00758797
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
54
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Photoimmunotherapy
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events. [24 weeks]

Secondary Outcome Measures

  1. Assess time to disease progression [24 weeks to years]

  2. Evaluate tumor response by measuring clinically apparent tumors throughout study. [24 weeks]

  3. Quantify overall survival in this study population [years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier:
NCT00758797
Other Study ID Numbers:
  • STU1213
First Posted:
Sep 25, 2008
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Keywords provided by Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
metastatic melanoma
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of Dec 3, 2021