Vaccination With Tumor mRNA in Metastatic Melanoma - Fixe... | NCT00204516

Studies
Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

NCT00204516

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jan 16, 2013Estimated

Enrollment

31Actual

Phase

Phase 1Phase 2

Conditions

Malignant Melanoma

Interventions

mRNA coding for melanoma associated antigens
GM-CSF

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Aug 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2013

Last Update Posted Date

Jan 16, 2013Estimated

Name	Class
German Research Foundation	OTHER

Description Module

Brief Summary

The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.

Detailed Description

vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mRNA Vacc	Experimental		Biological: mRNA coding for melanoma associated antigens Drug: GM-CSF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mRNA coding for melanoma associated antigens	Biological	mRNA vaccine s.c. applied weekly	mRNA Vacc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability	Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.	every 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

malignant melanoma stage III/IV
fresh frozen tumor tissue available
informed consent given
Karnofsky >= 70%

Exclusion Criteria:

brain metastasis
parallel chemotherapy
systemic treatment with glucocorticoids
other malignancies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claus Garbe, Prof. Dr.	University of Tuebingen, Department of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, University of Tuebingen		Tübingen		72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016178	Granulocyte-Macrophage Colony-Stimulating Factor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided