A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen.
- Histologically confirmed metastatic melanoma, head and neck cancer, transitional cell
carcinoma, sarcoma, GIST (gastrointestinal stroma tumor) or prostate cancer
- Tumor expression of 1) NY-ESO-1 by reverse transcriptase and polymerase chain
reaction (RT-PCR) analysis (see Appendix 1), preferably, or immunohistochemistry
- Expected survival of at least 6 months.
- Karnofsky performance scale >/-70 %.
- Fully recovered from surgery.
- Declined, intolerated or completed standard therapy defined as following for each
- Melanoma- Resistance or intolerance to Dacarbazine.
- Sarcoma-Resistance or intolerance to Anthracyclines and to one Platinum
containing chemotherapy regimen, no indication for irradiation.
- GIST (gastrointestinal stroma tumor)- Failure or intolerance of Imatinib and
- Head and Neck Cancer -No indication for irradiation, resistance or intolerance
to platinum containing chemotherapy.
- Transitional Cell Carcinoma - Resistance or intolerance to Cisplatin combined
- Prostate Cancer- Failure of antihormonal treatment and resistance or intolerance
- Within the last 2 weeks prior to study day 1, vital laboratory parameters should be
within normal range, except for the following laboratory parameters, which should be
within the ranges specified:
- Absolute neutrophil count (ANC) >/- 1,000/mm3
- Platelets >/-75,000/mm3
- Creatinine - 2 mg/dL
- ALT, AST - 5 x ULN
- Alk Phos and total bilirubin - 2.5 x ULN
- Age ≥ 18 years
- Able and willing to give valid written informed consent
- Clinically significant heart disease (NYHA Class III or IV).
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding
- Patients with serious intercurrent illness, requiring hospitalization.
- Known HIV positivity
- Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose
of study agent (6 weeks for nitrosoureas).
- Known autoimmune disease (RA, SLE), as these conditions might interfere with the
evaluation of the induced immune response. Patients with vitiligo or
melanoma-associated hypopigmentation are not excluded.
- Chronic use of immunosuppressive drugs such as systemic corticosteroids.
- Other malignancy within 3 years prior to entry into the study, except for treated
non-melanoma skin cancer and cervical carcinoma in situ.
- Mental impairment that may compromise the ability to give informed consent and comply
with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to first dosing of study agent.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of