Lung Neoplasms Clinical Trial
Official title:
A Phase I/II Study of Tergenpumatucel-L (HyperAcute Lung) an Antitumor Vaccination Using Alpha (1,3) Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Non-Small Cell Lung Cancer
This 2-phase study will determine the safety of treating patients with non-small cell lung
cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the
proper vaccine dose and will examine side effects and potential benefits of the treatment.
The vaccine contains killed lung cancer cells containing a mouse gene that causes the
production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the
immune response to the foreign substance will stimulate the immune system to attack the
patient's own cancer cells that have similar proteins without this sugar pattern, causing the
tumor to remain stable or shrink.
Patients 18 years of age or older with non-small cell lung cancer that has recurred or no
longer responds to standard treatment may be eligible for this study. Candidates will be
screened with a medical history and physical examination, blood tests, urinalysis, chest
x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be
obtained if needed.
Participants will receive four vaccinations a month apart from each other. The vaccines will
be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of
the study will treat successive groups of patients with increasing numbers of the vaccine
cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will
look for any beneficial effects of the vaccine given at the highest dose found to be safe in
Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In
addition, patient follow-up visits will be scheduled every 2 months for the first year after
vaccination and then every 3 months for the next 2 years for the following tests and
procedures to evaluate treatment response and side effects:
- Medical history and physical examination
- Blood tests
- X-rays and various scans (nuclear medicine/CT/MRI)
- FACT-L Assessment questionnaire to measure the impact of treatment on the patient's
general well-being. The questionnaire is administered before beginning treatment, before
each vaccination, and during follow-up visits after completing the treatment. It
includes questions on the severity of lung cancer symptoms and the ability to perform
normal activities of daily life.
In addition to the above procedures, 3 skin punch biopsies will be done at the vaccination
site to look for a local immune response. For this procedure, an area of skin is numbed with
an anesthetic and a 4 mm (about 1/4-inch) circular area is removed, using a sharp cookie
cutter-type instrument. Also, one blood sample per year will be collected for the next 15
years to monitor the safety of the gene transfer. Patients whose lung cancer spreads to the
skin, superficial soft tissues, or a superficial lymph node may be asked to undergo a biopsy
of the lesion to see what effect the treatment may be having on the tumor.
Background:
- Lung cancer remains the leading cause of cancer death with an estimated 174,400 new
cases and 162,400 deaths each year in the U.S.
- Despite attempts at early diagnosis and the development of new therapeutic agents, there
has been only limited improvement in the outcome for patients with advanced lung cancer.
- A enzyme called alpha(1,3)galactosyltranferase (alphaGT) that is not found in humans can
transfer sugars on to proteins in human cells that can make them highly immunogenic and
cause them to be rejected by the body.
- Antitumor vaccination using killed donor human lung cancer cells expressing alphaGT may
stimulate immune responses in patients against their own lung cancer because their lung
cancer may share antigens with the vaccine cells that have been made more immunogenic by
expression of alphaGT.
Objectives:
Phase I has been completed.
Phase II
- To assess the tumor response rate of anti-tumor vaccination using irradiated allogeneic
lung cancer cell lines genetically engineered to express the murine
alpha(1,3)galactosyltransferase enzyme in patients with advanced, recurrent or
refractory non-small cell lung cancer.
- To assess the immunological response of patients with lung cancer undergoing antitumor
vaccination with irradiated allogeneic lung cancer cell lines genetically engineered to
express murine alpha(1,3)galactosyltransferase.
- Assess the survival distribution as well as the duration of response.
Eligibility:
- Non-small cell lung cancer (Adenocarcinoma, squamous cell carcinoma, large cell
anaplastic carcinoma and bronchoalveolar carcinoma).
- Stage IV, recurrent or treatment refractory disease.
- No exclusion for prior therapy. Prior therapy may include surgery, radiation,
immunotherapy, and chemotherapy regimens. EGFR inhibitors or monoclonal antibodies are
included as chemotherapy.
- Patients must have a granulocyte count of greater than or equal to 1000/microL,
platelets greater than or equal to 100,000/microL, hemoglobin greater than 10.0 gm/dL,
albumin greater than or equal to 3.0 gm/dL and acceptable hepatic and renal function.
- No systemic corticosteroids.
Design (Phase II):
- Patients will be intradermally vaccinated with 300 million
alpha(1,3)galactosyltranferase-expressing vaccine cells every 2-weeks to complete a
total of eight vaccinations.
- Patients will be monitored for tumor and immunological responses and safety.
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