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Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides

Phase 1/Phase 2
19 Years
90 Years
Open (Enrolling)
Malignant Melanoma, Pancreatic Cancer, Colon Cancer, Cervical Cancer

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Trial Information

Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides

As prognosis of advanced melanoma, pancreatic, colon and cervical cancer remains gloomy, new
therapeutic modalities have to be developed to improve the patient´s clinical outcome.
Immunotherapy, which targets tumor associated antigens of tumor cells or tumor stroma, is
currently an intensively investigated, novel therapeutic option. As survivin is expressed
both by neoplastic cells as well as by endothelial cells of the tumor vasculature, this
antigen is an intriguing target molecule. Spontaneous cytotoxic T-cell responses against
different survivin epitopes in cancer patients underline the relevance of survivin-directed
immunological trials. This study is comprised of a peptide vaccine with HLA-A1, -A2 and -B35
restricted survivin epitopes in Montanide ISA-51 for patients with stage IV melanoma,
advanced pancreatic, colon and cervical carcinoma. The vaccine is applicated as a deep
subcutaneous injection. Vaccination is administered for the first 2 months weekly,
afterwards every 4 weeks. Standard staging examinations are performed every three months.
Clinical, laboratory and immunological monitoring is done every month.Diagnostic
leucapheresis is performed before first vaccination and afterwards every 2 months.

Inclusion Criteria:

- Advanced melanoma, pancreatic, colon and cervical cancer

- At least 1 prior postoperative conventional therapy (chemotherapy, radiation,

- HLA-A1, -A2, -B35

- More than 4 weeks since last chemo-, immune- or radiotherapy

- ECOG-PS (Eastern Cooperative Oncology Group- Performance Status) of 0-1

- Sufficient renal, hepatic and bone marrow function: thrombocytes > 75.000/ul; hb > 9
g/dl; leucocytes > 2.500/ul; creatinine < 2 mg/dl; GOT/GPT < twice the normal value

- negative for HIV and Hbs

- Older than 18 years

- Informed consent

Exclusion Criteria:

- Acute/chronic infections

- Positive for HIV, Hbs

- Autoimmune disorders

- Pregnancy, breast feeding

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:

Progression-free survival

Principal Investigator

Juergen C Becker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Dermatology, University of Wuerzburg, Germany


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

April 2003

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Pancreatic Cancer
  • Colon Cancer
  • Cervical Cancer
  • Peptide vaccine therapy
  • Survivin
  • Colonic Neoplasms
  • Uterine Cervical Neoplasms
  • Melanoma
  • Pancreatic Neoplasms