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

Metastatic Cancer Clinical Trial

Official title:

Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453050
• Other study ID #: CDR0000536471
• Secondary ID: OU-12576OU-ISPI
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2007
• Last updated: May 5, 2015
• Start date: March 2006

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

Primary

• Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared laser therapy with or without indocyanine green in patients with stage III or IV melanoma and cutaneous metastases.

• Determine the complete systemic and local response rates in patients treated with this regimen.

Secondary

• Determine the effect of this treatment on immunologic parameters in these patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma meeting the following criteria:

• Stage III or IV disease

• Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed

• Presence of 1 or more cutaneous metastases = 3 cm in size

• Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness

• No uncontrolled brain metastases

• Treated brain metastases that are stable for 3 months allowed at the investigator's discretion

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy = 4 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 month after study completion

• No known allergy to any drugs used during study treatment

• No unstable medical illness

• Not immunosuppressed

• Patients immunosuppressed due to disease (e.g., HIV positive) allowed

PRIOR CONCURRENT THERAPY:

• No systemic steroids or any other immunosuppressive medications within the past month

• No chemotherapy within the past 4 weeks

• No radiotherapy to the treatment site within the past 4 weeks

• Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed

• No concurrent immunosuppressive agents

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• imiquimod

• indocyanine green solution

Other:
• flow cytometry

• immunologic technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Oklahoma University Cancer Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (2)

Li X, Naylor MF, Le H, Nordquist RE, Teague TK, Howard CA, Murray C, Chen WR. Clinical effects of in situ photoimmunotherapy on late-stage melanoma patients: a preliminary study. Cancer Biol Ther. 2010 Dec 1;10(11):1081-7. doi: 10.4161/cbt.10.11.13434. Epub 2010 Dec 1. — View Citation

Naylor MF, Chen WR, Teague TK, Perry LA, Nordquist RE. In situ photoimmunotherapy: a tumour-directed treatment for melanoma. Br J Dermatol. 2006 Dec;155(6):1287-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity and tolerability by CTCAE version 3.0			Yes
Primary	Complete systemic and local response rates at 16 months			No
Secondary	Immunologic parameters			No