Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00336986




Registration number
NCT00336986
Ethics application status
Date submitted
14/06/2006
Date registered
15/06/2006
Date last updated
14/08/2023

Titles & IDs
Public title
Efficacy Study of IL-21 to Treat Metastatic Melanoma
Scientific title
An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma
Secondary ID [1] 0 0
NN028-1614
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - recombinant interleukin-21

Treatment: Drugs: recombinant interleukin-21
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumor size assessed according to international criteria
Timepoint [1] 0 0
After 8 weeks
Secondary outcome [1] 0 0
Serum levels of antibodies against recombinant human IL-21.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Markers of immunomodulation in blood.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Safety evaluation.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Time to progression.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Histologically confirmed surgically incurable metastatic melanoma

- Patients must have measurable disease

- ECOG performance status of 0 or 1

- Expected life expectancy at least 4 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of and signs/symptoms of uncontrolled brain metastases or edema.

- Previous treatment with chemotherapy or any biological anti-cancer drug (prior
adjuvant therapy with interferon-alpha is permitted as long as treatment was completed
at least six months prior to study entry.)

- Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.

- Receipt of any investigational drug for treatment of metastatic melanoma prior to this
trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - East Melbourne
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Heidelberg
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Malvern
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Nedlands
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At
least 14 to a maximum of 40 patients, who have not previously received treatment for their
stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00336986
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR; 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries