Symptoms and General Pathology

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Nevus

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Anti-Infective Agents

All Drugs and Chemicals

Ganciclovir

Ganciclovir triphosphate

Antiviral Agents

Enzyme Inhibitors

adenovirus RSV-TK

ganciclovir

John C. Morris, MD

RATIONALE: Inserting a modified herpesvirus gene into a person's melanoma cells may make the cancer more sensitive to the antiviral agent ganciclovir.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have stage IV melanoma.

OBJECTIVES: I. Determine the maximum tolerated dose of ganciclovir administered IV every 12 hours for 7 days in combination with adenovirus RSV-TK administered by direct intralesional injection in patients with cutaneous or subcutaneous metastatic malignant melanoma. II. Determine the dose limiting toxicities of this regimen in this patient population. III. Evaluate the response (both local and at distant metastatic sites), duration of response, response by ganciclovir dose, and any impact local treatment with adenovirus RSV-TK and ganciclovir "suicide" gene therapy may have on overall survival in these patients.

OUTLINE: This is a dose escalation study of ganciclovir. Patients are stratified according to response of the index lesion and other metastatic disease sites. Patients receive an intratumoral injection of adenovirus RSV-TK on day 1. Ganciclovir IV is administered every 12 hours on days 3-10 for a total of 14 doses. Patients sustaining a partial response (PR) or complete response (CR) may be retreated 2 weeks after documented PR or CR. Cohorts of 3-6 patients receive escalating doses of ganciclovir until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed at 3 weeks, 4 weeks, 60 days, then every 2 months for 6 months, and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

Gene Therapy and Ganciclovir in Treating Patients With Stage IV Melanoma

A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene (AdV.RSV-TK) in Combination With Escalating Doses of Ganciclovir in Patients With Cutaneous Metastatic Malignant Melanoma

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

gene expression analysis

mutation analysis

immunohistochemistry staining method

laboratory biomarker analysis

examination

mutation carrier screening

study of high risk factors

Contact Person

Julia Newton Bishop, MD

RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.

PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

OBJECTIVES:

Primary

* Determine what lifestyle factors and which genes govern relapse from melanoma.

Secondary

* Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
* Assess how unusual moles relate to sun exposure and genes that cause melanoma.

OUTLINE: This is a multicenter, cohort study.

Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients\* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).

NOTE: \*Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.

Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.

Patients and healthy participants are followed annually.

Peer reviewed and funded or endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.

Study of Families With Melanoma

Melanoma Family Case-Control Study Protocol

Leeds Cancer Centre at St. James's University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene Therapy and Ganciclovir in Treating Patients With Stage IV Melanoma	NCT00005057	Melanoma (Skin)	adenovirus RSV-... ganciclovir	18 Years -	National Cancer Institute (NCI)
Gene Therapy and Ganciclovir in Treating Patients With Stage IV Melanoma	NCT00005057	Melanoma (Skin)	adenovirus RSV-... ganciclovir	18 Years -	National Cancer Institute (NCI)
Study of Families With Melanoma	NCT00445783	Melanoma (Skin)	gene expression... mutation analys... immunohistochem... laboratory biom... examination mutation carrie... study of high r...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for nodular malignant melanoma