A Novel Treatment for Metastatic Melanoma
This study is currently recruiting participants.
Verified March 2013 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00758797
First received: June 23, 2008
Last updated: March 26, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758797
Contacts
| Contact: Rosemara Hughart, MD | 312-695-1982 | rosemara.hughart@northwestern.edu |
| Contact: Emily Poon, PhD | 312-695-4761 | research.nuderm@northwestern.edu |
Locations
| United States, Illinois | |
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Rosemara Hughart, MD 312-695-1982 rosemara.hughart@northwestern.edu | |
| Contact: Emily Poon, PhD 312-695-4761 research.nuderm@northwestern.edu | |
| Principal Investigator: Murad Alam, MD | |
| Sub-Investigator: Timothy Kuzel, MD | |
| Sub-Investigator: Mary Martini, MD | |
| Sub-Investigator: Jeffrey Wayne, MD | |
| Sub-Investigator: Simon S. Yoo, MD | |
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: | March 26, 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 May 16, 2013