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A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma

2014-07-24 14:22:22 | BioPortfolio

Summary

The purpose of this research study is to find out whether JX-594 is safe and effective for treating surgically unresectable malignant melanoma.

Description

Cancer of the skin is the most common of all cancers, probably accounting for more than 50% of all cancers. Melanoma accounts for about 4% of skin cancer cases but causes a large majority of skin cancer deaths. The American Cancer Society estimates that about 62,190 new melanomas will be diagnosed in the United States during 2006.

DTIC is the only chemotherapy drug approved by the FDA for the treatment of metastatic melanoma. The reported response rates are 5-20% without any evidence of prolonged survival in randomized clinical trials versus best supportive care. The median overall survival for melanoma patients treated with DTIC alone is approximately 8 months; PFS and TTP following treatment with DTIC is approximately 7 weeks, and the objective response rate for DTIC alone (CR+PR) is less than 10% (Millward, 2004). Other chemotherapy agents including cisplatin and carboplatin, BCNU, vindesine, paclitaxel, docetaxel, and vinorelbine have also been tested but none have improved upon the very modest activity of DTIC.

Melanoma may be the optimal target for JX-594 immunotherapy because of the relatively high rate of accessible disease for injection, the positive response of melanoma seen with IL-2 immunotherapy, and the lack of effective, tolerable therapy for patient with metastatic melanoma. Furthermore, it is speculated that JX-594 replication targets the EGFR pathway, which is highly expressed in melanocytes.

Results from an initial Phase I/II study suggest that intratumoral injection of JX-594 is safe and effective in treating both injected and distant disease in patients with surgically incurable metastatic melanoma. Response of both injected tumors (in 5 of 7 patients) and response of at least one non-injected tumor (in 4 of 7 patients) was demonstrated, including two patients who achieved a partial response (6 + months) and a complete response (4 + months) to JX-594 treatment. Particularly noteworthy is that efficacy and gene expression occurred despite pre-treatment vaccination (and, therefore, pre-existing anti-vaccinia immunity) in all patients.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

JX-594

Location

UCLA
Los Angeles
California
United States
90095

Status

Completed

Source

Jennerex Biotherapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:22:22-0400

Clinical Trials [929 Associated Clinical Trials listed on BioPortfolio]

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine...

Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

The purpose of this study is to examine the health behaviors of melanoma survivors. We want to know about their thoughts and concerns. Melanoma is a type of skin cancer. The number of peop...

The Impact of Melanoma and Drug Treatment in the Real World

An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the kno...

Vaccination Plus Ontak in Patients With Metastatic Melanoma

The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the d...

Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients

This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma peptide vaccine in combination or not with Dacarbazine administration in melanoma patients

PubMed Articles [891 Associated PubMed Articles listed on BioPortfolio]

Impact of primary care provider density on detection and diagnosis of cutaneous melanoma.

Early diagnosis of cutaneous melanoma is critical in preventing melanoma-associated deaths, but the role of primary care providers (PCPs) in diagnosing melanoma is underexplored. We aimed to explore t...

Thymoquinone induces apoptosis in B16-F10 melanoma cell through inhibition of p-STAT3 and inhibits tumor growth in a murine intracerebral melanoma model.

Prognosis of patients with melanoma brain metastasis is poor despite various chemotherapeutic agents. Researchers focus on finding effective treatment with low risk of toxicity. Thymoquinone (TQ) has ...

Melanoma in situ mimicking a Lichen planus-like keratosis.

The incidence of melanoma has steadily increased over the past three decades. Melanoma in situ (MIS),  defined as melanoma that is limited to the epidermis, contributes to a disproportionately high p...

MALDI MSI of MeLiM melanoma: Searching for differences in protein profiles.

Treatment of advanced cutaneous melanoma remains challenging, and new data on melanoma biology are required. The most widely accepted criteria for the prognostic evaluation of melanoma are histopathol...

Melanoma in US Hispanics: recommended strategies to reduce disparities in outcomes.

Cutaneous melanoma is the most fatal form of skin cancer and presents a considerable public health concern in the United States. Although the age-adjusted incidence of melanoma among US Hispanics is l...

Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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