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

NCT ID: NCT00453050

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31

Brief 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.

Detailed 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.

Conditions

Melanoma (Skin); Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

imiquimod

Intervention Type: DRUG

indocyanine green solution

Intervention Type: DRUG

flow cytometry

Intervention Type: OTHER

immunologic technique

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Principal Investigators

Mark Naylor, MD

Role: STUDY_CHAIR

University of Oklahoma

Locations

Oklahoma University Cancer Institute

Tulsa, Oklahoma, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20890121 (View on PubMed)

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. doi: 10.1111/j.1365-2133.2006.07514.x.

Reference Type: BACKGROUND

PMID: 17107404 (View on PubMed)

Other Identifiers

OU-12576

Identifier Type: -

Identifier Source: secondary_id

OU-ISPI

Identifier Type: -

Identifier Source: secondary_id

CDR0000536471

Identifier Type: -

Identifier Source: org_study_id