Know Cancer

forgot password

A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma



- To assess the efficacy, in terms of objective response rate, nonprogression rate, time
to progression, and response duration, in patients with metastatic or recurrent
malignant melanoma treated with recombinant human interleukin-21 (rIL-21).

- To assess the toxicity and safety of rIL-21 in patients with previously untreated
metastatic or recurrent malignant melanoma.

- To characterize the pharmacokinetics of rIL-21.

- To characterize the effects of rIL-21 on lymphocyte cell count and soluble CD25 (sCD25)
in serum as potential biomarkers for drug activity.

- To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to
the drug and antibody induction during treatment.

- To assess melanoma antigenic markers for response and nonprogression on archival tissue
from patients enrolled on the study.


- To investigate whether rIL-21 induced sCD25 release is independent of the level of
circulating sCD25.

- To investigate the effect of rIL-21 on antibody induction during treatment and
preexisting immunogenicity.

- To assess lymphocyte cell-count changes over time in relation to rIL-21 therapy.

OUTLINE: This is a multicenter study.

Patients receive recombinant human interleukin-21 (rIL-21) IV on days 1-5 of weeks 1, 3 and
5. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable
toxicity. Patients achieving a complete response (CR) or partial response (PR) receive 2
courses beyond CR or PR. Patients with stable disease receive a maximum of 3 courses of

Previously archived tumor tissue and blood samples are collected from patients for
correlative studies. Samples are analyzed for soluble CD25, rIL-21 antibodies, circulating
lymphocyte counts, preexisting immonogenicity to rIL-21 for antibody induction, and
expression of common melanoma tumor antigen markers via IHC.

After completion of study treatment, patients are followed at 4 weeks.

Inclusion Criteria


- Histologically confirmed cutaneous malignant melanoma

- Recurrent or metastatic disease that is not curable by surgical or other means

- Clinically and/or radiologically documented disease defined as at least one site of
disease unidimensionally measurable ≥ 20 mm by x-ray, physical exam, or nonspiral CT
scan OR ≥ 10 mm by spiral CT scan

- Must have nonbulky metastatic disease defined as the largest measurable lesion ≤ 50
mm in maximum diameter

- Must have primary diagnosis tumor tissue or previously resected metastatic melanoma
tissue available (i.e., paraffin block or unstained slides)

- No known brain metastases


- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Absolute granulocytes count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception during study therapy

- No uncontrolled intercurrent illness or condition including, but not limited to, any
of the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study

- No history of hemolysis or a hemolytic disorder including, but not limited to, any of
the following:

- Sickle cell anemia

- Thalassemia

- Autoimmune hemolytic anemia

- No history of other malignancies within the past 5 years except adequately treated
nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other
solid tumors curatively treated with no evidence of disease

- No known HIV, hepatitis B, or hepatitis C infection

- Patients must reside within a 2-hour drive from a participating center


- No previous systemic therapy for metastatic disease

- At least 3 months since prior adjuvant immunotherapy for recurrent melanoma

- No prior immunotherapy for metastatic disease

- No prior immunotherapy outside the adjuvant setting

- At least 4 weeks since prior major surgery

- At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive
radiotherapy and recovered

- More than 4 weeks since prior and no concurrent investigational agents or anticancer

- No prior chemotherapy including regional therapy

- No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone)

- Concurrent topical steroids are allowed

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumor response as assessed by RECIST

Outcome Time Frame:

after completion of treatment

Safety Issue:


Principal Investigator

Teresa M. Petrella

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook


Canada: Health Canada

Study ID:




Start Date:

July 2007

Completion Date:

July 2012

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma