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Sponsored by: |
Oklahoma Health Sciences Center - Tulsa |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00453050 |
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.
Condition | Intervention | Phase |
Melanoma (Skin) Metastatic Cancer |
Drug: imiquimod Drug: indocyanine green solution Procedure: flow cytometry Procedure: immunologic technique Procedure: laboratory biomarker analysis |
Phase I |
MedlinePlus related topics: | Cancer Melanoma |
ChemIDplus related topics: | S 26308 Indocyanine green |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study |
Estimated Enrollment: | 70 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, open-label, pilot study.
Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and 28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by flow cytometry), and antibody response (by western blot).
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma meeting the following criteria:
Stage III or IV disease
Presence of 1 or more cutaneous metastases ≤ 3 cm in size
No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Not immunosuppressed
PRIOR CONCURRENT THERAPY:
No radiotherapy to the treatment site within the past 4 weeks
United States, Oklahoma | |||||
Oklahoma University Cancer Institute | Recruiting | ||||
Tulsa, Oklahoma, United States, 74135-2512 | |||||
Contact: Mark Naylor, MD 918-619-4466 |
Oklahoma Health Sciences Center - Tulsa |
Study Chair: | Mark Naylor, MD | Oklahoma Health Sciences Center - Tulsa |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000536471, OU-12576, OU-ISPI |
First Received: | March 27, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00453050 |
Health Authority: | Unspecified |
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