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Tracking Information | |||||||||
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First Received Date † | January 9, 2004 | ||||||||
Last Updated Date | April 9, 2009 | ||||||||
Start Date † | December 2003 | ||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00075790 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
Immunological response as measured by an assay of serum anti-alpha-gal titers and enzyme-linked immunospot assay for interferon-gamma and interleukin-5 pre-treatment and at 6 months after completion of study treatment [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Vaccine Therapy in Treating Patients With Advanced Refractory or Recurrent Non-Small Cell Lung Cancer | ||||||||
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 | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase I, Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Open Label | ||||||||
Condition † | Lung Cancer | ||||||||
Intervention † | Biological: alpha-1,3-galactosyltransferase-expressing allogeneic lung tumor cell vaccine | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 52 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00075790 | ||||||||
Responsible Party | John Charles Morris, NCI - Metabolism Branch;MET | ||||||||
Secondary IDs †† | NCI-04-C-0049, NLGC-0101 | ||||||||
Study Sponsor † | National Cancer Institute (NCI) | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | December 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |