Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

NCT00514085 | Completed Phase 2 DMC

• 5 other identifiers: I189CAN-NCIC-IND189IND.189ZYMOGENETICS-CAN-NCIC-IND189CDR0000560973
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Interleukin-21 may stimulate white blood cells, including natural killer cells, to kill melanoma cells. PURPOSE: This phase II trial is studying the side effects and how well interleukin-21 works in treating patients with metastatic or recurrent malignant melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (6)

• Objective tumor response as assessed by RECIST

  after completion of treatment

• Overall response rate (complete and partial)

  after completion of study

• Stable disease rate

  after completion of study

• Progressive disease rate

  after completion of study

• Median time to progression

  after completion of study

• Response duration (median and range)

  after completion of study

Study Arms (1)

Recombinant human interleukin-21

EXPERIMENTAL

Biological: recombinant human interleukin-21; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

recombinant human interleukin-21 BIOLOGICAL

Patients enrolled in Part A will receive treatment daily x 5 on weeks 1, 3, and 5 of an 8 week cycle. Patients enrolled in Part B will receive treatment daily x 5 on weeks 1, and 3 of a 6 week cycle

Recombinant human interleukin-21

immunohistochemistry staining method OTHER

Cycle 1 Day 1 and Cycle 1 Day 29

Recombinant human interleukin-21

laboratory biomarker analysis OTHER

slides will be blocked for 15 minutes in 20% normal goat serum and then incubated in primary antibody

Recombinant human interleukin-21

pharmacological study OTHER

Starting dose of 50μg/kg/day as an IV push

Recombinant human interleukin-21

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 requirements * 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 PRIOR CONCURRENT THERAPY: * 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 therapy * No prior chemotherapy including regional therapy * No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone) * Concurrent topical steroids are allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• ZymoGenetics: collaborator

Study Sites (7)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• Petrella TM, Tozer R, Belanger K, Savage KJ, Wong R, Smylie M, Kamel-Reid S, Tron V, Chen BE, Hunder NN, Hagerman L, Walsh W, Eisenhauer EA. Interleukin-21 has activity in patients with metastatic melanoma: a phase II study. J Clin Oncol. 2012 Sep 20;30(27):3396-401. doi: 10.1200/JCO.2011.40.0655. Epub 2012 Aug 20.

  PMID: 22915661 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Teresa M. Petrella

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: December 13, 2007
• Primary Completion: September 2, 2010
• Study Completion: July 4, 2012
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)