NCT00108875

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2005

Completed
Last Updated

July 28, 2006

Status Verified

June 1, 2005

First QC Date

April 19, 2005

Last Update Submit

July 27, 2006

Conditions

Malignant MelanomaPancreatic CancerColon CancerCervical Cancer

Keywords

Peptide vaccine therapySurvivin

Outcome Measures

Primary Outcomes (3)

  • Progression-free survival

  • Overall survival

  • Immunological response

Secondary Outcomes (1)

  • Best response

Interventions

Survivin peptide vaccineBIOLOGICAL

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute/chronic infections
  • Positive for HIV, Hbs
  • Autoimmune disorders
  • Pregnancy, breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julius-Maximilians-University of Wuerzburg, Germany, Department of Dermatology

Würzburg, Bavaria, 97080, Germany

RECRUITING

Related Publications (7)

  • Blanc-Brude OP, Mesri M, Wall NR, Plescia J, Dohi T, Altieri DC. Therapeutic targeting of the survivin pathway in cancer: initiation of mitochondrial apoptosis and suppression of tumor-associated angiogenesis. Clin Cancer Res. 2003 Jul;9(7):2683-92.

    PMID: 12855648BACKGROUND

  • Otto K, Andersen MH, Eggert A, Keikavoussi P, Pedersen LO, Rath JC, Bock M, Brocker EB, Straten PT, Kampgen E, Becker JC. Lack of toxicity of therapy-induced T cell responses against the universal tumour antigen survivin. Vaccine. 2005 Jan 4;23(7):884-9. doi: 10.1016/j.vaccine.2004.08.007.

    PMID: 15603888BACKGROUND

  • Andersen MH, Pedersen LO, Capeller B, Brocker EB, Becker JC, thor Straten P. Spontaneous cytotoxic T-cell responses against survivin-derived MHC class I-restricted T-cell epitopes in situ as well as ex vivo in cancer patients. Cancer Res. 2001 Aug 15;61(16):5964-8.

    PMID: 11507035BACKGROUND

  • Andersen MH, Pedersen LO, Becker JC, Straten PT. Identification of a cytotoxic T lymphocyte response to the apoptosis inhibitor protein survivin in cancer patients. Cancer Res. 2001 Feb 1;61(3):869-72.

    PMID: 11221872BACKGROUND

  • Kim HS, Shiraki K, Park SH. Expression of survivin in CIN and invasive squamous cell carcinoma of uterine cervix. Anticancer Res. 2002 Mar-Apr;22(2A):805-8.

    PMID: 12014654BACKGROUND

  • Reker S, Becker JC, Svane IM, Ralfkiaer E, Straten PT, Andersen MH. HLA-B35-restricted immune responses against survivin in cancer patients. Int J Cancer. 2004 Mar 1;108(6):937-41. doi: 10.1002/ijc.11634.

    PMID: 14712500BACKGROUND

  • Reker S, Meier A, Holten-Andersen L, Svane IM, Becker JC, thor Straten P, Andersen MH. Identification of novel survivin-derived CTL epitopes. Cancer Biol Ther. 2004 Feb;3(2):173-9. doi: 10.4161/cbt.3.2.611. Epub 2004 Feb 1.

    PMID: 14726703BACKGROUND

MeSH Terms

Conditions

MelanomaPancreatic NeoplasmsColonic NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Juergen C Becker, MD

    Department of Dermatology, University of Wuerzburg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juergen C Becker, MD, PhD

CONTACT

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

Marion B Wobser

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2005

First Posted

April 20, 2005

Study Start

April 1, 2003

Last Updated

July 28, 2006

Record last verified: 2005-06

Locations

DE(1)