Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
Public ClinicalTrials.gov record NCT01579318. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter Phase II Trial of Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor activity of ImmunoPulse IL-12® in participants with stage IB to IIIB mycosis fungoides. ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid \[tavo\]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid \[DNA\] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). All participants may receive up to four cycles of treatment consisting of three treatment days, Days 1, 5 and 8, in a 12-week cycle as per Protocol version 6 (see Limitations and Caveats section of this record for protocol version information). Patients will receive intra-tumoral injection of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells.
Study identification
- NCT ID
- NCT01579318
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2 participants
Conditions and interventions
Interventions
- Tavokinogene Telseplasmid (tavo) Biological
- OncoSec Medical System (OMS) Device
Biological · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2012
- Primary completion
- Jun 2, 2014
- Completion
- Jun 2, 2014
- Last update posted
- May 14, 2023
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Helen Diller Comprehensive Cancer Center | San Francisco | California | 94115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01579318, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 14, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01579318 live on ClinicalTrials.gov.