Trial of pIL-12 Electroporation Malignant Melanoma (IL12MEL)
This study is currently recruiting participants.
Verified February 2013 by OncoSec Medical Incorporated
Sponsor:
OncoSec Medical Incorporated
Information provided by (Responsible Party):
OncoSec Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01502293
First received: December 21, 2011
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
Study Title: A Multicenter Phase II trial of intratumoral pIL-12 electroporation in advanced stage cutaneous and in transit malignant melanoma
Design: Single-arm, open-label, multicenter Phase II interventional trial
Sample size: 25 evaluable subjects
Sample accrual: 10 per year
Population: Patients with AJCC stage IIIB, IIIC or IV M1a melanoma with cutaneous or in transit lesions accessible to electroporation
Regimen: One 8-day cycle of IL-12 plasmid, 0.5 mg/ml X 1ml intratumorally, with electroporation on days 1, 5, and 8. If there is evidence of persistent disease after 180 days (6 months) and no evidence of systemic progression, patients may be retreated every 3 months at the investigator's discretion. Otherwise, only 1 cycle of treatment will be given.
Objectives: Primary:
• To determine the 24-week distant response rate (complete and partial) of patients with advanced cutaneous melanoma treated with IL-12 plasmid electroporation
Secondary:
- Local response rate
- Progression free survival
- Overall survival
- Duration of distant response
- Time to objective response
- Safety of intratumoral IL-12 in vivo electroporation
Exploratory:
• To describe the immunologic effects of IL-12 plasmid electroporation:
- Induction of intratumoral IL-12 and IFN-gamma within electroporated melanoma tumors
- Proportion of tumor-infilitrating lymphocyte subsets such as regulatory (FoxP3+) T cells at baseline and post-treatment
- Proportion of circulating lymphocyte subsets such as regulatory (FoxP3+) and effector (CD25+CD69+CD4+ and CD25+CD69+CD8+) T cells at baseline and post-treatment
- Antigen-specific cellular and humoral immune responses in peripheral blood at baseline and post-treatment and whether this is associated with clinical response
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: Plasmid INTERLEUKIN-12 Device: Intratumoral Electroporation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma |
Resource links provided by NLM:
Further study details as provided by OncoSec Medical Incorporated:
Primary Outcome Measures:
- Distant response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]The distant response rate of patients treated with IL-12 plasmid electroporated in vivo into cutaneous melanoma lesions.
Secondary Outcome Measures:
- Local response rate and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]The local response rate, progression free survival and overall survival of IL-12 plasmid electroporation.
- Safety and adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The safety of IL-12 plasmid electroporation as assessed by adverse events.
- Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]The duration of response and time to objective response.
| Estimated Enrollment: | 25 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: plasmid Interleukin-12 |
Biological: Plasmid INTERLEUKIN-12
Each patient will have three treatments applied to two to four lesions; these will be on days 1, 5 and 8. Therefore the maximum plasmid dose injected per patient will be as follows: Plasmid Concentration = 0.5 mg/mL; Maximum volume that can be injected in one patient on a given day, distributed over 2-4 lesions = 1 mL; Maximum plasmid injected on a given day = 0.5 mg; Maximum plasmid injected in one patient over one cycle = 1.5 mg Electrical discharge around the tumor site resulting in electroporation of plasmid DNA into tumor cells. Each patient will have three treatments applied to two to four lesions; these will be on days 1, 5 and 8. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically documented melanoma, AJCC stage IIIB, IIIC or IV M1a with cutaneous melanoma lesions accessible to electroporation. Patients with Stage IIIB or IIIC disease may have cutaneous in-transit disease or cutaneous satellitosis and patients with Stage IV M1a disease may have either of these with distant cutaneous metastatic sites.
- Age ≥ 18 years old
- 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 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.
- Must have a minimum of two eligible tumors and may have up to four eligible tumors treated with electroporation.
- Creatinine < 2 x upper limit of normal, and serum bilirubin within institutional normal limits obtained within 4 weeks prior to registration.
- Absolute neutrophil count (ANC) > 1000/mm and platelet count > 100,000 /mm within 4 weeks prior to registration.
- Able to give informed consent and able to follow guidelines given in the study
Exclusion Criteria:
- Prior therapy with IL-12 or prior gene therapy
- Concurrent immunotherapy, chemotherapy, or radiation therapy
- Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
- 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.
- Life expectancy of less than 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502293
Locations
| United States, California | |
| UCSF Helen Diller Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Rebecca Bolthouse 415-514-6714 bolthouser@cc.ucsf.edu | |
| Principal Investigator: Adil Daud, MD | |
| John Wayne Cancer Institute | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: MaDonna Johnson 310-582-7438 JohnsonM@JWCI.ORG | |
| Principal Investigator: Mark B Faries, MD | |
| United States, Florida | |
| Lakeland Regional Cancer Center | Recruiting |
| Lakeland, Florida, United States, 33805 | |
| Contact: Robin S Stewart, RN, PhD 863-904-1877 robin.stewart@lrmc.com | |
| Principal Investigator: Manuel A Molina, MD | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Nichole Real 206-288-7476 nreal@seattlecca.org | |
| Principal Investigator: Shailender Bhatia | |
Sponsors and Collaborators
OncoSec Medical Incorporated
Investigators
| Principal Investigator: | Adil Daud, MD | University California San Francisco |
| Study Director: | Paul Goldfarb, M.D. | OncoSec Medical Incorporated |
More Information
No publications provided
| Responsible Party: | OncoSec Medical Incorporated |
| ClinicalTrials.gov Identifier: | NCT01502293 History of Changes |
| Other Study ID Numbers: | 11854 |
| Study First Received: | December 21, 2011 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interleukin-12 Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013