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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), June 2009
First Received: January 9, 2004   Last Updated: June 5, 2009   History of Changes
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

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

Resource links provided by NLM:


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, 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
Investigators
Study Chair: John C. Morris, MD NCI - Metabolism Branch;MET
Investigator: Charles Joseph Link, MD NewLink Genetics Corporation
  More Information

Additional Information:
Publications:
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.

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

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
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 04, 2009