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A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen.

Phase 1
18 Years
Open (Enrolling)
Melanoma, Sarcoma, Gastrointestinal Stromal Tumor (GIST), Head and Neck Cancer, Transitional Cell Carcinoma, Prostate Cancer

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Trial Information

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen.

Inclusion Criteria:

- 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
tumor entity:

- 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
with Gemcitabine

- Prostate Cancer- Failure of antihormonal treatment and resistance or intolerance
to Docetaxel

- 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
- Alk Phos and total bilirubin
- Age ≥ 18 years

- Able and willing to give valid written informed consent

Exclusion Criteria:

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events.

Outcome Time Frame:

Duration of study

Safety Issue:


Principal Investigator

Elke Jaeger, Prof.Dr. med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Krankenhaus Nordwest


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

May 2007

Completion Date:

April 2013

Related Keywords:

  • Melanoma
  • Sarcoma
  • Gastrointestinal Stromal Tumor (GIST)
  • Head and Neck Cancer
  • Transitional Cell Carcinoma
  • Prostate Cancer
  • MBV
  • Mixed Bacterial Vaccine
  • NY-ESO-1
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Head and Neck Neoplasms
  • Melanoma
  • Prostatic Neoplasms
  • Gastrointestinal Stromal Tumors
  • Sarcoma