Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer
Conditions
Malignant Melanoma - Pancreatic Cancer - Colon Cancer - Cervical Cancer
Conditions: official terms
Melanoma - Pancreatic Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
Peptide vaccine therapy, Survivin
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Survivin peptide vaccine
Type: Biological
Overall Status
Recruiting
Summary
This study evaluates the safety, the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and cervical carcinoma.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- Advanced melanoma, pancreatic, colon and cervical cancer

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

- 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
Location
Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology
Wuerzburg, Bavaria, Germany
Status: Recruiting
Contact: Juergen C Becker, MD, PhD - +49-931-201-26396 - becker_jc@klinik.uni-wuerzburg.de
Start Date
April 2003
Sponsors
Julius-Maximilians University
Source
Julius-Maximilians University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page