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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00108875
Enrollment
70
Registered
2005-04-20
Start date
2003-04-30
Completion date
Unknown
Last updated
2006-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Colon Cancer, Malignant Melanoma, Pancreatic Cancer

Keywords

Peptide vaccine therapy, Survivin

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.

Interventions

BIOLOGICALSurvivin peptide vaccine

Sponsors

Julius-Maximilians University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression-free survival
Overall survival
Immunological response

Secondary

MeasureTime frame
Best response

Countries

Germany

Contacts

Primary ContactJuergen C Becker, MD, PhD
becker_jc@klinik.uni-wuerzburg.de+49-931-201-26396
Backup ContactMarion B Wobser
wobser_m@klinik.uni-wuerzburg.de+49-931-201-26722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026