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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075790 |
Purpose
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 Genetic: protein analysis Genetic: western blotting Other: enzyme-linked immunosorbent assay Other: immunohistochemistry staining method |
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: | 58 |
| 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 followed by a phase II study. (Phase I is closed to accrual as of 10/06/09)
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.
Some patients undergo tumor tissue biopsies at baseline and within 28 days of last vaccination for cellular immune response by IHC assays. Blood samples are also collected at baseline and periodically during study for immune response by ELISA, total immunophenotyping by FACS, and Western Blot.
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 54 patients will be accrued for this study within 3-4 years.
Eligibility| 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:
Patients should have:
NSCLC sites that are accessible to needle, punch, or other limited biopsy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Prior surgery, radiotherapy, immunotherapy, and/or chemotherapy regimens for NSCLC, including neoadjuvant and adjuvant treatment, allowed
Endocrine therapy
No concurrent systemic corticosteroids
Radiotherapy
Surgery
Other
Contacts and Locations| 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 |
More Information
| 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: | October 14, 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 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 |