Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00601861

Purpose

The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma

Condition	Intervention	Phase
Malignant Melanoma Cancer	Drug: recombinant interleukin-21	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Interleukin-21

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of Recombinant Interleukin-21 on the Lymph Node Pathology in Patients With Stage III Melanoma.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Complete pathological response rate in the lymph nodes [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Immunomodulatory effects [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Relapse free survival [ Time Frame: For up to 4 years after the final visit or until progression of the disease in order to assess the relapse free survival (RFS) ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	January 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: recombinant interleukin-21 Fixed and equal dose for s.c. injection, 3 times weekly

Detailed Description:

The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The trial was terminated as a result of a strategic decision by the sponsoring company

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage III melanoma
ECOG performance status 0-1

Exclusion Criteria:

Signs of stage IV melanoma
Safety variables

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601861

Locations

Germany

Berlin, Germany, 10119

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Paul Kristjansen, MD, PhD, DMSc

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN028-1801, EudraCT No: 2006-005350-79
Study First Received:	January 3, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00601861 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma

Nevus
Skin Neoplasms
Melanoma, Familial
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 06, 2009