Advertisement

Topics

Gene Therapy in Treating Patients With Metastatic Melanoma

2014-08-27 03:57:36 | BioPortfolio

Summary

RATIONALE: Inserting the gene for interleukin-2 into a person's melanoma cells may make the body build an immune response to kill tumor cells.

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

Description

OBJECTIVES: I. Determine the maximum tolerated dose of liposome complexed staphylococcal enterotoxin B and interleukin-2 plasmid DNA in patients with metastatic melanoma. II. Determine local gene expression in tumor tissues in this patient population treated with this regimen. III. Determine if plasmid DNA can be detected in circulation following intratumoral injection of this regimen in this patient population. IV. Evaluate the antitumor immune responses induced by this treatment regimen in these patients. V. Characterize the clinical response to this treatment regimen in terms of tumor size and histology in these patients. VI. Determine the clinical response to this treatment regimen in terms of complete remission, partial remission, stable disease, and disease progression in these patients.

OUTLINE: This is a dose escalation study. Patients receive intratumoral liposome complexed staphylococcal enterotoxin B (SEB) and interleukin-2 (IL-2) plasmid DNA injections into 1-3 tumor nodules once every 2 weeks. Treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete regression during therapy may receive additional therapy to previously untreated tumor nodules. Patients with partial response at 4 weeks following the last injection may continue therapy once every 4 weeks until no residual tumor remains. Cohorts of 3 patients each receive escalating doses of SEB and IL-2 plasmid DNA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities. Patients are followed until death.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Melanoma (Skin)

Intervention

aldesleukin, staphylococcal enterotoxin B

Location

University of Colorado
Denver
Colorado
United States
80262

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:36-0400

Clinical Trials [1762 Associated Clinical Trials listed on BioPortfolio]

Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

This phase II trial studies the best dose of aldesleukin when given together with pembrolizumab to see how well they work in treating patients with stage III-IV melanoma. Aldesleukin may s...

Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bi...

Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma

RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin togeth...

Cyclophosphamide or Cellular Adoptive Immunotherapy With or Without Aldesleukin in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bi...

Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immu...

PubMed Articles [3945 Associated PubMed Articles listed on BioPortfolio]

Prevalence of Enterotoxin Genes in Staphylococcus aureus Isolates from Pork Production.

In this study, 130 Staphylococcus aureus isolates from samples associated with pork production were tested for prevalence of 18 staphylococcal enterotoxin (SE) genes. Approximately 94.6% (123/130) of ...

Risk of skin cancer in people with vitiligo: a systematic review and meta-analysis.

Vitiligo is a chronic disorder causing skin depigmentation with around 1% global prevalence, affecting people of all ages, skin types and genders. Due to the absence of melanin in lesional skin there ...

Staphylococcus aureus enterotoxins modulate IL-22-secreting cells in adults with atopic dermatitis.

Atopic dermatitis (AD) is a chronic inflammatory immune-mediated skin disease characterized by skin colonization by Staphylococcus aureus. Interleukin (IL)-22, in cooperation with IL-17, triggers anti...

Inverse association for diagnosis of Alzheimer's disease subsequent to both melanoma and non-melanoma skin cancers in a large, urban, single center, Midwestern U.S. patient population.

Although literature demonstrates a decreased risk of Alzheimer's disease (AD) in individuals with various cancers, including squamous cell cancers (SCC) and basal cell cancers (BCC) comprising non-mel...

Mohs micrographic surgery for digital melanoma and nonmelanoma skin cancers.

Treatment of digital skin cancers is challenging due to various functional and cosmetic implications. Traditionally, routine treatment includes radical amputation, but digital skin cancers are increas...

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)

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.

Infections to the skin caused by bacteria of the genus STAPHYLOCOCCUS.

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

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

More From BioPortfolio on "Gene Therapy in Treating Patients With Metastatic Melanoma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Bioinformatics
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Melanoma
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial