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

Phase 2TerminatedNCT00601861

Novo Nordisk A/S1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Malignant Melanoma

Interventions

recombinant interleukin-21DRUG

Fixed and equal dose for s.c. injection, 3 times weekly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stage III melanoma * ECOG performance status 0-1 Exclusion Criteria: * Signs of stage IV melanoma * Safety variables

Locations (1)

Novo Nordisk Investigational Site

Berlin, Germany

Outcomes

Primary Outcomes

Complete pathological response rate in the lymph nodes

Time frame: After 4 weeks of treatment

Secondary Outcomes

Safety

Time frame: For the duration of the trial

Immunomodulatory effects

Time frame: For the duration of the trial

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)

Data from ClinicalTrials.gov

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