Interleukin-12 Gene and in Vivo Electroporation- Mediated Plasmid DNA Vaccine Therapy in Treating Patients With Merkel Cell Cancer
Sponsored by OncoSec Medical Incorporated in collaboration
with National Cancer Institute, patients receive interleukin-12
gene intratumorally (IT) and undergo electrical discharge
around the tumor site for electroporation-mediated plasmid
DNA vaccine therapy on days 1, 5, and 8. Patients with unresectable
disease may receive a second course of treatment in
week 7. Patients with localized disease proceed to definitive
treatment as determined by the treating physician starting 2-4
weeks after the first injection. The primary objective is to measure
the effect of intratumoral injection of IL-12 plasmid (pIL-12)
(interleukin-12 gene) followed by in vivo electroporation (EP)
(electroporation-mediated plasmid DNA vaccine therapy) on
the local expression of interleukin-12 (IL-12) in the tumor microenvironment
in patients with Merkel cell carcinoma (MCC).
Patients must have biopsy-confirmed Merkel cell carcinoma
and at least one injectable lesion, defined as an easily palpable
superficial lesion (cutaneous, subcutaneous or lymph
nodal metastasis) that can be accurately localized, stabilized
by palpation, and is superficial enough to enable intratumoral
injection and electroporation; the injectable lesion must not be
in close proximity to another tissue (eg, nerve, bone) that could
put patient safety at risk. Patients who have had prior chemotherapy,
investigational therapy or a major surgical procedure
within 4 weeks or radiotherapy within 2 weeks prior to first
day of treatment and must not be receiving concurrently any
other anti-cancer treatment (including topical agents such as
imiquimod) or investigational agents, which could potentially
interfere with the study treatment and/or study endpoints.
High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs Periodic Clinical Nodal Observation
Sponsored by University of Pittsburgh, this is a prospective,
randomized, non-blinded, controlled trial of high risk head and
neck cutaneous squamous cell carcinomas which will compare specific outcomes between two treatment arms. Subjects are
eligible patients who are sent to Zitelli & Brodland PC for Mohs
micrographic surgery of tumors that meet our high-risk criteria.
These patients with clinically-negative lymph node exams will
either enter into the arm of nodal observation or the arm of
elective management of the neck, which is currently the standard
protocol per the UPMC ENT department. The patients in
the observation arm will have evaluation and treatment of their
lymph nodes if an abnormality is detected clinically. The primary
endpoint is disease-specific survival. Secondary endpoints
will include overall and disease-free survival, complications,
and quality of life measures for each arm.
Inclusion criteria must be greater than 6 mm depth of invasion
and greater than 2cm diameter. High-risk locations include
any portion of cutaneous lip, ear, temple, and scalp. Exclusion
criteria include satellite metastases, clinically abnormal lymph
node exam, previous head and neck radiation, and pregnancy.
A Randomized, Double-Blind Phase II, Study of Gemcitabine Alone or in Combination With Pazopanib for Refractory Soft Tissue Sarcoma
Sponsored by OHSU Knight Cancer Institute in collaboration
with GlaxoSmithKline, the purpose of this randomized phase
II trial studies how well gemcitabine hydrochloride works with
or without pazopanib hydrochloride in treating patients with
refractory soft tissue sarcoma. Drugs used in chemotherapy,
such as gemcitabine hydrochloride, work in different ways
to stop the growth of tumor cells, either by killing the cells
or by stopping them from dividing. Pazopanib hydrochloride
may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Pazopanib hydrochloride
may also stop the growth of tumor cells by blocking blood
flow to the tumor. It is not yet known whether gemcitabine
hydrochloride is more effective with or without pazopanib
hydrochloride in treating patients with soft tissue sarcoma
the primary goal is to investigate whether treatment with
gemcitabine (gemcitabine hydrochloride) plus pazopanib
(pazopanib hydrochloride) improves the median progression-