Vaccine Maintenance Treatment for Non-Small Cell Lung Cancer

NCT00420732 | Terminated Phase 2 DMC

• 2 other identifiers: NLG0201OBA#0611-820
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the response rate of the administration of HyperAcute-Lung Cancer Vaccine for subjects with stage IIIB or stage IV non-small cell lung cancer who have been treated with first line platinum-doublet therapy and have responded or are considered to have stable disease.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• To determine the response rate of the administration of HyperAcute® Lung (HAL) Cancer Vaccine cells by injection into subjects with stage IIIB (pleural effusion) or stage IV non-small cell lung carcinoma who have been treated with first line platinum-dou

  4 months

Secondary Outcomes (1)

• To conduct correlative scientific studies of subject samples to determine the mechanism of any observed antitumor effect. In these studies human humoral and cellular immune responses to HAL cells will be evaluated.

  while on study

Study Arms (1)

Vaccine Group

EXPERIMENTAL

Biological: HyperAcute-Lung Cancer Vaccine

Interventions

HyperAcute-Lung Cancer Vaccine BIOLOGICAL

300 million cells given intradermally every 3 weeks for up to a total of 12 vaccinations

Also known as: HAL-1, HAL-2, HAL-3

Vaccine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histological diagnosis of non-small cell lung cancer. Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed NSCLC/small cell, and variant large and small are not eligible.
• AJCC Stage IIIB(pleural effusion) or Stage IV NSCLC
• Subjects must have been previously treated with only a first line platinum-doublet therapy that may or may not include Avastin(R). Those treated with definitive chemo-radiation with curative or palliative intent or who have received multiple regimens are not eligible.
• Subjects' NSCLC must have responded or remained stable through first line platinum-doublet therapy.
• ECOG Performance Status ≤ 2.
• Serum albumin ≥ 3.0 gm/dL.
• Expected survival ≥ 6 months.
• Hemoglobin ≥ 9.0 g/dl
• Platelets ≥ 100,000 cells/mm3
• ANC ≥ 1500 cells/mm3
• Serum total bilirubin ≤ 2 x ULN, ALT and AST ≤ 2.5 x ULN (≤5 if hepatic metastasis is present).
• Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 ml/min.
• Measurable or non-measurable disease.
• Subjects must have negative serology for HIV prior to entering study.
• Male and female subjects of child bearing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving experimental drug, and for one month after the last immunization.

You may not qualify if:

• Age \< 18 years.
• Active CNS metastases or carcinomatous meningitis.
• Subjects' whose NSCLC progressed during/after first line platinum-doublet therapy.
• Subjects having undergone splenectomy.
• Hypercalcemia \> 2.9 mmol/L, unresponsive to standard therapy.
• Pregnant or nursing women.
• Other malignancy within the last 5 years, unless the probability of recurrence of the prior malignancy is \< 30%. Patient's curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or subjects with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
• History of organ transplant.
• Current, active treatment with immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
• Subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible.
• Significant or uncontrolled congestive heart failure, myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
• Active infection or antibiotics within 1-week prior to study, including unexplained fever.
• Autoimmune disease.
• Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study.
• A known allergy to any component of the vaccine.

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charles J. Link, Jr., M.D.

  NewLink Genetics Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2014
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

US (2)