Vaccine Therapy in Treating Patients With Advanced Refractory or Recurrent Non-Small Cell Lung Cancer

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Vaccine Therapy in Treating Patients With Advanced Refractory or Recurrent Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: 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
Phase I
Phase II




MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
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


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Adverse effects, dose-limiting toxicity, and maximum tolerated dose as measured by CTCAE v.3 and RECIST criteria pre-treatment, during study treatment, and 6 months after completion of study treatment (phase I) [ Designated as safety issue: Yes ]

Tumor response rate as measured by CTCAE v.3 and RECIST criteria pre-treatment, during study treatment, and 6 months after completion of study treatment (phase II) [ Designated as safety issue: No ]



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 ]


Estimated Enrollment: 52
Study Start Date: December 2003
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

Determine the side effects, dose-limiting toxicity, and maximum tolerated dose of vaccination comprising α-1,3-galactosyltransferase-expressing allogeneic tumor cells (HyperAcute™ Lung Cancer Vaccine) in patients with advanced refractory or recurrent non-small cell lung cancer.
Determine tumor response rate in patients treated with this vaccine.
Secondary

Determine the immunological response in patients treated with this vaccine.
Determine the survival distribution and duration of response in patients treated with this vaccine.
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.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer (NSCLC)

The following cellular subtypes are eligible:

Bronchoalveolar (papillary) carcinoma
Squamous cell (epidermoid)
Adenocarcinoma
Large cell anaplastic
Must meet criteria for 1 of the following stages:

Stage IV (any T, any N, M1)
Metastatic
Progressive or recurrent
Failed at least 1 prior chemotherapy regimen OR refused chemotherapy for NSCLC
Measurable or nonmeasurable disease
No mixed NSCLC and small cell lung carcinoma or variant large and small cell lung carcinoma
No active CNS metastases or carcinomatous meningitis
Ineligible for other curative intent treatment (e.g., surgical resection)
PATIENT CHARACTERISTICS:

Age

18 and over
Performance status

ECOG 0-2
Life expectancy

At least 4 months
Hematopoietic

Hemoglobin ≥ 10.0 g/dL
Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Absolute lymphocyte count ≥ 475/mm^3
Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 2.5 times ULN
Albumin ≥ 3.0 g/dL
Hepatitis B and C negative
No liver cirrhosis
Renal

Creatinine ≤ 1.5 times ULN OR
Creatinine clearance ≥ 50 mL/min
No hypercalcemia > 2.9 mmol/L that is unresponsive to standard therapy (e.g., IV hydration, diuretics, calcitonin, and/or bisphosphonate therapy)
Cardiovascular

No significant or uncontrolled congestive heart failure
No myocardial infarction within the past 6 months
No significant ventricular arrhythmias within the past 6 months
Pulmonary

No significant pulmonary dysfunction
A history of asthma or mild active asthma is allowed
Immunologic

HIV negative
No active infection or unexplained fever (i.e., temperature > 38.1°C)
No autoimmune disease (e.g., systemic lupus erythematosus or active rheumatoid arthritis)
No known allergy to any component of the study drug or cell lines from which it was derived
Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study participation
No other malignancy within the past 5 years except malignancies for which the probability of recurrence is less than 5%, curatively treated squamous cell or basal cell skin cancer, or carcinoma in situ of the cervix
No other serious medical condition that would limit life expectancy to less than 2 years
No other medical or psychiatric condition (e.g., untreated schizophrenia or other significant cognitive impairment) that would preclude study participation
PRIOR CONCURRENT THERAPY:

Biologic therapy

See Chemotherapy
At least 4 weeks since prior biological or targeted therapy
Chemotherapy

See Disease Characteristics
No more than 2 prior chemotherapy or immunotherapy regimen for NSCLC, including neoadjuvant and adjuvant treatment

Preoperative neoadjuvant and postoperative (within 12 weeks after surgery) adjuvant chemotherapy with the same agent is considered 1 prior regimen
Gefitinib, erlotinib, monoclonal antibodies, or other small molecule or targeted therapies will be considered as prior chemotherapy or immunotherapy
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy

No concurrent systemic corticosteroids

Concurrent inhaled or topical corticosteroids are allowed
No concurrent replacement therapy for hypoadrenalism
Radiotherapy

At least 4 weeks since prior radiotherapy
Surgery

No prior organ transplantation
At least 4 weeks since prior major surgery
Other

Recovered from all prior therapy (except alopecia and fatigue)
More than 1 week since prior antibiotics
No concurrent tacrolimus
No other concurrent immunosuppressive therapy
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075790


Locations
United States, Georgia
Medical College of Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Stacy Haun, RN, BSN 706-721-3453
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

Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: John C. Morris, MD NCI - Metabolism Branch;MET
Investigator: Charles Joseph Link, MD NewLink Genetics Corporation

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database
Web site for additional information
Featured trial article

Publications of Results:
Morris JC, Janik JE, Vahanian N, et al.: A phase I study of antitumor vaccination using genetically modified tumor cells expressing (1,3) galactosyltransferase in patients with refractory or recurrent non-small cell lung cancer (NSCLC): preliminary results. [Abstract] American Society of Gene Therapy: 8th Annual Meeting, 1-5 June, 2005, St. Louis, MO. A-1133, 2005.
Morris JC, Vahanian N, Janik JE, et al.: Phase I study of an antitumor vaccination using α(1,3) galactosyltransferase expressing allogeneic tumor cells in patients (Pts) with refractory or recurrent non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-2586, 187s, 2005.

Study ID Numbers: CDR0000349373, NCI-04-C-0049, NLGC-0101
Study First Received: January 9, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00075790 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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