Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma
- age of 18 or older
- ECOG performance score 0 or 1
- Histologically proven soft tissue sarcoma
- Unresectable or metastatic soft tissue sarcoma
- Ability to give written informed consent
- Objective measured and measurable tumor lesions
- The failure of standard therapy
- Adequate amount of material for genetic research
- No active or chronic infection with HIV, Hepatitis B or Hepatitis C
- Men/Women of childbearing potential must use adequate contraception
- Hematology, liver function and renal function lab tests within required parameters
- Untreated or uncontrolled brain metastases.
- History of other active malignancy within last 2 years, except adequately treated
other soft tissue sarcoma.
- Autoimmune disease (vitiligo is not a basis for exclusion).
- Serious uncontrolled medical disorder or active infection that would impede
- Underlying medical or psychiatric condition that would cause administration vaccine
- Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine
- Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or
cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration;
other investigational therapies; chronic use of systemic corticosteroids (however, a
low stable dose steroid for mild brain edema or adrenal insufficiency is allowed;
topical and inhaled standard dose corticosteroids are allowed).
- Dementia or significantly altered mental status that would prohibit understanding or
rendering of informed consent and compliance with protocol requirements.
- Pregnant or breastfeeding women.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g. infectious) illness.