Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy

NCT00534209 | Terminated Phase 1 Results DMC

• 3 other identifiers: 20057158SCCC-2005042WIRB-20051678
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung cancer who have finished first-line chemotherapy.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Preliminary Safety Profile (Phase 1)

  This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.

  Up to 13 weeks

• Progression-free Survival (Phase 2)

  Date of randomization to the earliest date of documented progression.

Secondary Outcomes (6)

• Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)

  About 13 weeks

• Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)

  From Week 1 of Study Therapy until Death or Withdrawal of Consent

• Safety Profile (Phase 2)

  About 13 weeks

• Response to Second-line Chemotherapy After Disease Progression (Phase 2)

  From Week 1 of Study Therapy until Death or Withdrawal of Consent

• Overall Survival (Phase 2)

  Date of randomization to the recorded date of death

Study Arms (2)

Arm I: Allogeneic B7.1/HLA-A1

EXPERIMENTAL

Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally.

Biological: Allogeneic B7.1/HLA-A1

Arm II: Placebo

PLACEBO COMPARATOR

Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.

Other: Placebo

Interventions

Allogeneic B7.1/HLA-A1 BIOLOGICAL

Dose: At least 4x10\^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally

Also known as: - B7.1, - B7, - Ad100-B45-Neo-B7.1-HLA A1 or HLA2

Arm I: Allogeneic B7.1/HLA-A1

Placebo OTHER

Given intradermally

Arm II: Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with stage IIIB (non-candidates for radiation) or stage IV pathologically confirmed non-small cell carcinoma of the lung that completed 4-6 cycles of platinum based first line chemotherapy and achieved complete response (CR), partial response (PR) or stable disease.
• Last administration of chemotherapy occurred no later than 4 weeks prior to the enrollment date.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min.
• Pulmonary Function Requirements:
• All patients will undergo evaluation of pulmonary function prior to enrollment.
• Patients should have a Forced expiratory volume in 1 second (FEV1) more than 30% of the predicted value and/or Diffusing capacity (DLCO) more than 30% of the predicted value with a partial pressure of carbon dioxide (PCO2) \< 45mm.
• Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, congestive heart failure (CHF) or pulmonary embolism (PE)) will have request pulmonary function test (PFT) evaluation and if the above parameters are seen will be excluded from the protocol.
• Age ≥ 18 years.
• Signed informed consent.
• Patients should have absolute neutrophil count (ANC) ≥ 1000/mm3; platelets (PLT) ≥ 80,000/mm3.

You may not qualify if:

• Small cell carcinoma of the lung.
• Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study.
• Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
• Concomitant steroid or other immunosuppressive therapy.
• Active infection, or less than 7 days since therapy for acute infections.
• Pericardial effusion.
• Currently receiving chemotherapy for another condition (such as arthritis).
• Time elapsed greater than 4 weeks since last administration of first line chemotherapy for NSCLC.
• Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction.
• Pregnant or lactating women (negative test for pregnancy required of women of childbearing potential).
• Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
• Known HIV infection
• Untreated or uncontrolled brain metastasis.
• Liver Enzymes greater than 3 times the institutional upper limit.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Raez LE, Cassileth PA, Schlesselman JJ, Padmanabhan S, Fisher EZ, Baldie PA, Sridhar K, Podack ER. Induction of CD8 T-cell-Ifn-gamma response and positive clinical outcome after immunization with gene-modified allogeneic tumor cells in advanced non-small-cell lung carcinoma. Cancer Gene Ther. 2003 Nov;10(11):850-8. doi: 10.1038/sj.cgt.7700641.

  PMID: 14605671 BACKGROUND

• Frankowski DJ, Raez J, Manners I, Winnik MA, Khan SA, Spontak RJ. Formation of dispersed nanostructures from poly(ferrocenyldimethylsilane-b-dimethylsiloxane) nanotubes upon exposure to supercritical carbon dioxide. Langmuir. 2004 Oct 12;20(21):9304-14. doi: 10.1021/la049646l.

  PMID: 15461522 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

B7-1 Antigen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

B7 Antigens; Intercellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors

Limitations and Caveats

Study closed early due to low enrollment. A minimum of 2 patients were required for Phase 1, however, this requirement was not met.

Results Point of Contact

• Title: Luis Raez MD
• Organization: UM/Sylvester Comprehensive Cancer Center

lraez@med.miami.edu

305-243-4909

Study Officials

• Luis E. Raez, MD, FACP

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 16, 2017
• Results First Posted: February 20, 2013

Record last verified: 2017-09

Locations

US (2)