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Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy

Phase 1
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an
immunogenic human tumor cell vaccine, and assess immune response in relation to clinical

Primary Aim:

- to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic
tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC.

Secondary Aims:

- to study the immune response to vaccination,

- to monitor clinical responses and

- to recommend a dose-schedule combination for further testing in an initial Phase II
trial of vaccine efficacy.

Inclusion Criteria

Inclusion Criteria

- Histologically confirmed NSCLC (squamous, adeno-, large cell anaplastic,
bronchoalveolar, and non-small cell carcinoma NOS): stage IIIB with malignant pleural
effusion, stage IV, or recurrent disease.

- At least one site of bi-dimensionally measurable disease.

- Metastasis if present and treated must be stable by CT scan or MRI for at least 8

- Patient must have received and failed at least one line of chemotherapy.

- Age >= 18 years.

- ECOG performance status 0-2.

- Life expectancy >= 3 months.

- Laboratory parameters:

- Hemoglobin levels >= 10.0 (transfusions allowed if necessary).

- ANC >= 1,500.

- Platelets >= 100k.

- Creatinine clearance >= 50 ml/min.

- Total and direct bilirubin: < 2.5 X upper institution limit for normal.

- Liver function tests: AST, ALT, and AlkP < 2.5 X upper institution limit for

- Signed informed consent.

- Autopsy consent - although not a requirement for study entry, patients who consent to
participate in study will be made aware of the critical importance of a post-mortem
examination in the event of the patient's death after receiving therapy with this
experimental vaccine. Therefore, pre-treatment written agreement to autopsy will be
sought from the patient, or verbal agreement to autopsy will be sought in the
presence of the next of kin or other family members.

Exclusion Criteria

- Active or symptomatic cardiac disease such as congestive heart failure, angina
pectoris or recent myocardial infarction. Patients with history of these conditions
who are stable taking cardiac medications will also be excluded.

- Pregnant or lactating women (negative test for pregnancy is required of women of
childbearing potential).

- Known HIV infection.

- Uncontrolled or untreated brain or spinal cord metastases.

- Active infection.

- Concomitant steroid or other immunosuppressive therapy.

- Other active malignancies present within the past three years, except for basal
and/or squamous cell carcinoma(s) or in situ cervical cancer.

- Alcohol or chemical abuse.

- Meningeal carcinomatosis.

- Chemotherapy, radiation therapy, or other anti-tumor therapy during the last four

- Prior biologic response modifier therapy.

- Refusal in fertile men or women to use effective birth control measures during and
for six months after the completion of treatment on study.

- Immune deficiency syndromes, including the following: rheumatoid arthritis, systemic
lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis,

- Compromised lung function:

- FeV1 < 30% of the predicted value, or

- DLCO < 30% of the predicted value, or

- PCO2 > 45 mmHg.

- Any patient enrolled on study whose respiratory symptoms have experienced marked
deterioration not related to a known cause, such as pneumonia, congestive heart
failure, or pulmonary embolism, will have a repeat PFT evaluation, and if the above
parameter values for FeV1, DLCO, or PCO2 are seen, will be excluded from further

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

6, 12, 18, 24, and 36 months post enrollment

Safety Issue:


Principal Investigator

Luis E. Raez, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136