Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma

Malignant Melanoma Clinical Trial

Official title:

Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323206
• Other study ID #: MCC-13224
• Status: Completed
• Phase: N/A
• First received: May 5, 2006
• Last updated: February 20, 2017
• Start date: June 2004
• Est. completion date: April 2008

Study information

• Verified date: January 2009
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have cytologically/histologically documented metastatic malignant melanoma with lesions near the skin that would be accessible to electroporation and Fine Needle Aspiration (FNA) and biopsy.

• Age > 18 years old

• Patients must have ECOG performance status 0-2

• Patients may have had prior chemotherapy or immunotherapy (with vaccines or Interferon or IL-2) with progression or persistent disease. All chemotherapy or immunotherapy must be stopped for 4 weeks prior to electroporation. Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be electroporated are within the radiation field. In addition, it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated.

• Patients must be able to give informed consent and able to follow guidelines given in the study

• Patients must have a minimum of two eligible tumors and may have up to four eligible tumors treated with electroporation.

Exclusion Criteria:

• Patients may not have had prior therapy with IL-12 or prior genetic therapy

• Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.

• Patients must have adequate renal and normal hepatic function (creatinine < 1.5 x upper limit of normal (ULN), bilirubin and SGOT (AST) within institutional normal limits) obtained within 4 weeks prior to registration.

• Patients must have absolute neutrophil count (ANC) > 1500/mm^3 and platelet count > 100,000 /mm^3 within 4 weeks prior to registration.

• Pregnant and breast feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.

• Women of childbearing age must have a negative pregnancy test and be willing to use a highly effective method of contraception. Men who are sexually active must also be willing to use an accepted and effective method of contraception.

• Patients with electronic pacemakers or defibrillators are excluded from this study as the effect of electroporation on these devices is unknown. Patients with significant cardiac arrhythmia's (including ventricular tachycardia, ventricular fibrillation or WPW syndrome) are also excluded.

• Patients with a history of epilepsy are excluded unless they have been seizure free over the last 5 years and are thought to be at low risk for seizure by their neurologist.

• Tumors that invade the bone, major blood vessels or nerves are ineligible because those tumors are contraindications to the use of electroporation.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Biological:
• IL-12p DNA
Plasmid IL-12 will be administered as an intratympanic (IT) injection.

Procedure:
• Intratumoral Electroporation
The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Gene Vector Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local and Systemic Expression of IL-12 and IFN Gamma	Cytokine expression measured by enzyme-linked immunosorbent assay (ELISA).	8 weeks
Primary	Maximum Tolerated Dose (MTD)	MTD of intralesionally electroporated IL-12 plasmid (pIL-12) as well as a recommended dose for Phase II study. Dose-Limiting Toxicity (DLT): will be defined as hematologic toxicities or diarrhea greater than grade 3, and nonhematologic toxicities greater than grade 2 as defined in the NCI common toxicity criteria, Version 3.0. Significant local skin breakdown, cellulitis, bleeding or ulceration will preclude treatment of particular tumor nodules although treatment of other nodules can continue.	8 weeks
Secondary	Local and Systemic Response	Number of participants with tumor response.	8 weeks

External Links

•   H Lee Moffiitt Cancer Center & Research Institute website