Know Cancer

or
forgot password

Phase 2a Study of IL-21 Assessing Tumour Size in Patients With Stage IV Malignant Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma, Cancer

Thank you

Trial Information

Phase 2a Study of IL-21 Assessing Tumour Size in Patients With Stage IV Malignant Melanoma


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

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor size assessed according to international criteria

Outcome Time Frame:

After 8 weeks

Safety Issue:

No

Principal Investigator

Birte K. Skrumsager, MSc

Investigator Role:

Study Director

Investigator Affiliation:

Novo Nordisk

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

NN028-1614

NCT ID:

NCT00336986

Start Date:

September 2004

Completion Date:

October 2007

Related Keywords:

  • Malignant Melanoma
  • Cancer
  • Melanoma

Name

Location