Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma
Summary
The purpose of this research study is to study a type of gene therapy treatment called plasmid electroporation. This type of treatment involves the injection of a gene into some melanoma tumors located near the surface of the skin, followed by a burst of electricity into the tumor to cause the tumor to take up the gene. This study is a Phase I study to determine the side effects and the correct dose of this type of treatment and also its effectiveness in treating melanoma. While the electroporation technique has been used in people, the combination of plasmid injection and electroporation is being tried in human beings for the first time.
Study Design
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Malignant Melanoma
Intervention
IL-12pDNA, electroporation
Location
H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
United States
33612
Status
Completed
Source
H. Lee Moffitt Cancer Center and Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00323206
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Melanoma, Amelanotic
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)
Iris Neoplasms
Tumors of the iris characterized by increased pigmentation of melanocytes. Iris nevi are composed of proliferated melanocytes and are associated with neurofibromatosis and malignant melanoma of the choroid and ciliary body. Malignant melanoma of the iris often originates from preexisting nevi.
Hutchinson's Melanotic Freckle
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.
Cysteinyldopa
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.
Dysplastic Nevus Syndrome
Clinically atypical nevi (usually exceeding 5 mm in diameter and having variable pigmentation and ill defined borders) with an increased risk for development of non-familial cutaneous malignant melanoma. Biopsies show melanocytic dysplasia. Nevi are clinically and histologically identical to the precursor lesions for melanoma in the B-K mole syndrome. (Stedman, 25th ed)
Clinical Trials
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drug...
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. I...
A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma
The purpose of this research study is to find out whether JX-594 is safe and effective for treating surgically unresectable malignant melanoma.
The Identification of Novel Prognostic Markers in Melanoma
The purpose of this project is to analyze tumour tissue from a group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital.
Clinical Study of Previously Untreated Patients With Malignant Melanoma
Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until comple...
PubMed Articles
Dermoscopic clues in the diagnosis of amelanotic and hypomelanotic malignant melanoma.
The clinical identification of amelanotic malignant melanoma (AMM) and hypomelanotic malignant melanoma (HMM) becomes difficult due to the lack of pigmentation and to the diverse clinical presentation...
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Metastatic malignant melanoma of the bladder is extremely rare in clinical practice with less than 10 cases reported in the last 30 years in the English literature. We report a case of malignant mela...
Ovarian malignant melanoma without evidence of teratoma.
A 46-year-old woman with ovarian malignant melanoma had advanced intraperitoneal metastasis, retroperitoneal and inguinal lymph node metastases. Extensive debulking surgery was performed and chemother...
Comparative Study of Anti-Oncogenic MicroRNA-145 in Canine and Human Malignant Melanoma.
MicroRNA (miRNA; miR)-145 is aberrantly expressed in most of human cancers, and plays a significant role in carcinogenesis and cancer progression. In the current study, we focused on how miR-145 plays...
