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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514085 |
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.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: recombinant human interleukin-21 Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma |
Estimated Enrollment: | 30 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 rIL-21.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous malignant melanoma
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness or condition including, but not limited to, any of the following:
No history of hemolysis or a hemolytic disorder including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 3 months since prior adjuvant immunotherapy for recurrent melanoma
No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone)
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Michael Smylie 780-432-8757 | |
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | Recruiting |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Contact: Gary K. Pansegrau 604-930-4064 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Kerry J. Savage 604-877-6000 | |
Canada, Manitoba | |
CancerCare Manitoba | Recruiting |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Contact: Ralph P.W. Wong 204-237-2006 | |
Canada, Ontario | |
Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Teresa M. Petrella 416-480-5248 | |
Margaret and Charles Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Richard G. Tozer 905-387-9495 | |
Canada, Quebec | |
Hopital Notre-Dame du CHUM | Recruiting |
Montreal, Quebec, Canada, H2L 4M1 | |
Contact: Karl Belanger 514-890-8200 |
Study Chair: | Teresa M. Petrella | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000560973, CAN-NCIC-IND189, IND.189, ZYMOGENETICS-CAN-NCIC-IND189 |
Study First Received: | August 8, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00514085 |
Health Authority: | Unspecified |
recurrent melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |