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 - Full Text View

Sponsor:	Oklahoma Health Sciences Center - Tulsa
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00453050

Purpose

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 Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis	Phase I

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: S 26308 Indocyanine green

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Toxicity and tolerability by CTCAE version 3.0 [ Designated as safety issue: Yes ]
Complete systemic and local response rates at 16 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunologic parameters [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	March 2006
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453050

Locations

United States, Oklahoma
Oklahoma University Cancer Institute
Tulsa, Oklahoma, United States, 74135-2512

Sponsors and Collaborators

Oklahoma Health Sciences Center - Tulsa

Investigators

Study Chair:

Mark Naylor, MD

Oklahoma Health Sciences Center - Tulsa

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00453050 History of Changes
Other Study ID Numbers:	CDR0000536471, OU-12576, OU-ISPI
Study First Received:	March 27, 2007
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III melanoma
stage IV melanoma
skin metastases

Additional relevant MeSH terms:

Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

Neoplastic Processes
Pathologic Processes
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on February 12, 2012