Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer

Trial Title: Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer

NCT ID: NCT00108875

Condition: Malignant Melanoma
Pancreatic Cancer
Colon Cancer
Cervical Cancer

Conditions: Official terms:
Melanoma
Uterine Cervical Neoplasms
BIRC5 protein, human

Conditions: Keywords:
Peptide vaccine therapy
Survivin

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Survivin peptide vaccine

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:
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

Gender: All

Minimum age: 19 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology

Address:
City: Wuerzburg
Zip: 97080
Country: Germany

Status: Recruiting

Contact:
Last name: Juergen C Becker, MD, PhD

Phone: +49-931-201-26396
Email: becker_jc@klinik.uni-wuerzburg.de

Contact backup:
Last name: Marion B Wobser

Phone: +49-931-201-26722
Email: wobser_m@klinik.uni-wuerzburg.de

Investigator:
Last name: Juergen C Becker, MD, PhD
Email: Principal Investigator

Start date: April 2003

Lead sponsor:
Agency: Julius-Maximilians University
Agency class: Other

Source: Julius-Maximilians University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00108875