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

Phase 1

• Conditions: Malignant Melanoma; Pancreatic Cancer; Colon Cancer; Cervical Cancer

• Registration Number: NCT00108875
• Lead Sponsor: Julius-Maximilians University

Brief 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-04-19
• Study First Submitted QC: 2005-04-19
• Study First Posted: 2005-04-20
• Status Verified: 2005-06
• Last Update Submitted: 2006-07-27
• Last Update Posted: 2006-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival
Overall survival
Immunological response

Secondary Outcome Measures

Name	Time	Method
Best response

Trial Locations

Locations (1)

Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology; 🇩🇪 Wuerzburg, Bavaria, Germany