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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075790 |
RATIONALE: Vaccines made from donor tumor cells may make the body build an immune response to kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with advanced refractory or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Biological: alpha-1,3-galactosyltransferase-expressing allogeneic lung tumor cell vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study Of An Antitumor Vaccination Using α(1,3) Galactosyltransferase Expressing Allogeneic Tumor Cells In Patients With Refractory Or Recurrent Non-Small Cell Lung Cancer |
Estimated Enrollment: | 52 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, open-label, dose-escalation study.
Patients receive vaccination comprising α-1,3-galactosyltransferase-expressing allogeneic tumor cells (HyperAcute™ Lung Cancer Vaccine [HAL]) intradermally on days 1, 29, 57, and 85 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of HAL vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6 patients receive treatment at the MTD.
Quality of life is assessed at baseline; days 29, 57, 85, 99, and 127; and then every 2 months for 1 year.
Patients are followed monthly for 1 year, every 3 months for 2 years, and then annually for 15 years.
PROJECTED ACCRUAL: A total of 52 patients (6-24 for phase I and 7-28 for phase II) will be accrued for this study within 3-4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
The following cellular subtypes are eligible:
Must meet criteria for 1 of the following stages:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior chemotherapy or immunotherapy regimen for NSCLC, including neoadjuvant and adjuvant treatment
Endocrine therapy
No concurrent systemic corticosteroids
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Contact Person 888-NCI-1937 |
Study Chair: | John C. Morris, MD | NCI - Metabolism Branch;MET |
Investigator: | Charles Joseph Link, MD | NewLink Genetics Corporation |
Responsible Party: | NCI - Metabolism Branch;MET ( John Charles Morris ) |
Study ID Numbers: | CDR0000349373, NCI-04-C-0049, NLGC-0101 |
Study First Received: | January 9, 2004 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00075790 History of Changes |
Health Authority: | Unspecified |
stage IV non-small cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer |
large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |