Vaccination of Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer With HLA-A1, -A2 and -B35 Restricted Survivin Peptides
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malignant Melanoma
- Sponsor
- Julius-Maximilians University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Last Updated
- 19 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Progression-free survival
Overall survival
Immunological response
Secondary Outcomes
- Best response