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

NCT ID: NCT00108875

Last Updated: 2006-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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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

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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.

Conditions

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Malignant Melanoma Pancreatic Cancer Colon Cancer Cervical Cancer

Keywords

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Peptide vaccine therapy Survivin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Survivin peptide vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Julius-Maximilians University

OTHER

Sponsor Role lead

Principal Investigators

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Juergen C Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University of Wuerzburg, Germany

Locations

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

Würzburg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Juergen C Becker, MD, PhD

Role: CONTACT

Phone: +49-931-201-26396

Email: [email protected]

Marion B Wobser

Role: CONTACT

Phone: +49-931-201-26722

Email: [email protected]

Facility Contacts

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Juergen C Becker, MD, PhD

Role: primary

Marion B Wobser

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 12855648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15603888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11507035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11221872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12014654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14712500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14726703 (View on PubMed)

Other Identifiers

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PEI 0899/01

Identifier Type: -

Identifier Source: secondary_id

IRB 07/03

Identifier Type: -

Identifier Source: secondary_id

SuMo-Sec-01

Identifier Type: -

Identifier Source: org_study_id