Immunization of Patients With Non Small Cell Lung Cancer (NSCLC)

NCT00793208 | Terminated Phase 1 DMC

• 1 other identifier: 08-004
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

The study of the vaccine will proceed in two stages after the method of Simon (102). In the first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic responses occur, the study will be terminated. If 3 or more responses are observed, the study will proceed to the second stage, accruing an additional 22 patients. If the second stage is complete and a total of 9 or more immunologic responses are observed among the 37 patients treated, the treatment response rate for the vaccine will be considered high enough to warrant further study. Conversely, if the evaluation of the vaccine concludes at the first stage, or if 8 or fewer total immunologic responses occur after completing the second stage, the vaccine will not be considered for further study.

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

Lung cancer; non small cell; vaccine; carcinoma; immunization; autologous Tumor; vaccination

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility; patients will be observed for treatment-related toxicity during and after each immunization,and for 1 h after immunization in the event that an immediate-type hypersensitivity reaction occurs.

  2.5 years

Secondary Outcomes (1)

• To evaluate the ability of the DNA-based vaccine to induce immune responses to the autologous tumor (if available) and/or the vaccine.

  14

Study Arms (1)

Vaccine

EXPERIMENTAL

vaccine composed of lethally irradiated semi-allogeneic human fibroblasts transfected with genomic tumor DNA from the patient's own tumor

Biological: semi-allogeneic human fibroblasts (MRC-5) transfected with DNA

Interventions

semi-allogeneic human fibroblasts (MRC-5) transfected with DNA BIOLOGICAL

Each vaccine consists of 1 x 10e7 DNA-transfected irradiated fibroblasts. A total of 4 weekly immunizations will be delivered to each patient. Each vaccine will be administered i.d. using a 1 mL syringe and a 25 gauge needle. Subjects will have immunizations administered at 4 different sites for each vaccination as follows: Site #1: Right arm Site #2: Left arm Site #3: Right thigh Site #4: Left thigh Approximately equal numbers of transfected fibroblasts will be administered at each site.

Vaccine

Eligibility Criteria

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

You may qualify if:

• Written informed consent conforming to the institutional guidelines obtained from the patient.
• A diagnosis of non-small cell lung cancer (NSCLC), subjects will undergo or have had surgical resection.
• Age 18 or above.
• Karnofsky performance status \> 70
• Adequate hematologic function:
• Absolute neutrophil count \> 1,000/mm3
• Absolute lymphocyte count \> 1,000/mm3
• Hemoglobin \> 9 g/dL
• Platelets \> 100,000/mm3
• Liver function tests:
• Bilirubin (total) \< 1.7 mg/dL
• Alkaline phosphatase \< 252 u/L
• SGOT \< 108 u/L
• Kidney profile:
• Serum electrolytes

You may not qualify if:

• Subjects will be EXCLUDED from participation in the study if any of the following apply:
• A significant history or current evidence of cardiac disease including, but not limited to: congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrythmias or myocardial infarction within the previous six months.
• Evidence of active infection requiring antibiotic therapy.
• Active intracranial metastases. Patients with previously resected intracranial disease and/or previously irradiated intracranial metastases that have been stable for four weeks are eligible.
• Pregnant or lactating women. Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated on study.
• Patients requiring systemic corticosteroids (unless patient has had NO STEROIDS IN THE PAST 4 WEEKS).
• Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
• Patient must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Subject is not a candidate for complete resection of the carcinoma via pneumonectomy, lobectomy, bilobectomy, extended wedge resection or anatomic segmentectomy with or without sleeve resection as noted in the surgical plan..
• Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to registration.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Theresa Whiteside, PhD: lead
• Immune Cell Therapy Inc.: collaborator

Study Sites (2)

University of Pittsburgh Cancer Institute - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma

Interventions

DNA

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mark A Socinski, MD

  UPCI/UPMC: Director, Lung Cancer Section, Division of Hematology/Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pathology,Director of the UPCI IMCPL Facility

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 19, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2015
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (2)