Autologous Tumor Cell Vaccs and ISCOMATRIX(TM) Adjuvant With Metronomic Oral Cyclophosphamide and Celecoxib in Pts Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura or Mediastinum

Inclusion Criteria

- INCLUSION CRITERIA:

1. Patients with sarcomas, melanomas, germ cell tumors, or epithelial malignancies
metastatic to the lungs, mediastinum, or pleura who can be rendered no evidence
of active disease (NED) following standard surgical therapy. Note: (Bullet)
Patients with active disease outside the thorax may be eligible for the study
once the extrathoracic disease is definitively treated by local modalities such
as radiation, surgery, or radiofrequency ablation.

2. Patients must have received or refused first line standard systemic therapy for
their metastases.

3. Patients with no more than 3 intracranial metastases, which have been
definitively treated by surgery or radiation therapy may be eligible for study
provided there is no evidence of active disease for at least 2 months.

4. Patients must have an ECOG performance status of 0 - 2.

5. Patients must be 18 years of age or older due to the unknown effects of
immunologic responses to germ cell-restricted gene products during childhood and
adolescent development.

6. Seronegative for HIV antibody. Note: The experimental treatment being evaluated
in this protocol depends on an intact immune system. Patients who are HIV
seropositive can have decreased immune competence and thus may be less
responsive to the experimental treatment.

7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
If hepatitis C antibody test is positive, then patient must be tested for the
presence of antigen by RT-PCR and be HCV RNA negative.

8. Patients must be aware of the neoplastic nature of their illnesses, the
experimental nature of the therapy, alternative treatments, potential benefits,
and risks.

9. Patients must be willing to sign an informed consent and undergo resection of
their malignancies at the NCI, to ensure vaccine development.

INCLUSION CRITERIA FOR TREATMENT PHASE OF PROTOCOL (Standard Consent):

1. Patients must have signed the Screening Consent.

2. Patients who were initially rendered NED by surgical resection must remain NED at the
time of treatment.

3. Patients with no more than 3 intracranial metastases, which have been definitively
treated by surgery or radiation therapy may be eligible for the study, provided there
is no evidence of active disease for at least 2 months and no requirement for
anticonvulsant therapy or steroids following treatment.

4. Patients must have an ECOG performance status of 0 - 2.

5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal
function as evidenced by the following laboratory parameters:

Absolute neutrophil count greater than 1500/mm3

Platelet count greater than 100,000/mm3

Hemoglobin greater than 8g/dl ( patients may receive transfusions to meet this
parameter

PT within 2 seconds of the ULN

Total bilirubin < 1.5 x upper limits of normal

Serum creatin ine less than or equal to 1.6 mg/ml or the creatinine clearance must be
greater than 70 ml/min/1.73m2.

6. Seronegative for HIV antibody. Note: The experimental treatment being evaluated in
this protocol depends on an intact immune system.

Patients who are HIV seropositive can have decreased immune competence and thus may
be less responsive to the experimental treatment.

7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If
hepatitis C antibody test is positive, then patient must be tested for the presence
of antigen by RT-PCR and be HCV RNA negative.

8. Patients must be willing to practice birth control during and for four months
following treatment.

9. Patients must be willing to sign the standard informed consent.

EXCLUSION CRITERIA

1. Patients requiring corticosteroids (other than inhaled) will be excluded.

2. Patients with life expectancy less than 12 months will be excluded.

3. Patients receiving warfarin anticoagulation, who cannot be transferred to other
agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held
for up to 24 hours will be excluded.

4. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease
evidenced by uncontrolled arrhythmias, unstable angina,decompensated CHF (> NYHA
Class II), or myocardial infarctionwithin 6 months of study will be excluded.

5. Patients with other cardiac diseases may be excluded at the discretion of the PI
following consultation with Cardiology consultants.

6. Patients with any of the following pulmonary function abnormalities will be excluded:
FEV, < 30% predicted; DLCO < 30% predicted (post-bronchodilator); pO2 < 60% or
pCO2 >= 50 on room air arterial blood gas.

7. Pregnant and/or lactating women will be excluded due to the unknown, potentially
harmful effects of immune response to CT-X antigens and stem cell proteins that may
be expressed in placenta, fetus, and neonates.

8. Patients with active infections, including HIV, will be excluded, due to unknown
effects of the vaccine on lymphoid precursors.