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

NCT00453050 | Completed Phase 1

• 3 other identifiers: CDR0000536471OU-12576OU-ISPI
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin); Metastatic Cancer

Keywords

stage III melanoma; stage IV melanoma; skin metastases

Outcome Measures

Primary Outcomes (2)

• Toxicity and tolerability by CTCAE version 3.0

• Complete systemic and local response rates at 16 months

Secondary Outcomes (1)

• Immunologic parameters

Interventions

imiquimod DRUG

indocyanine green solution DRUG

flow cytometry OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma University Cancer Institute

Tulsa, Oklahoma, 74135-2512, United States

Location

Related 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.

  PMID: 20890121 BACKGROUND

• 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.

  PMID: 17107404 BACKGROUND

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

Imiquimod; Flow Cytometry; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mark Naylor, MD

  University of Oklahoma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Last Updated: May 6, 2015

Record last verified: 2008-11

Locations

US (1)