Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00082914|
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 20, 2013
RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin)||Biological: denileukin diftitox||Phase 2|
- Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox.
- Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: Patients are stratified according to disease type (metastatic melanoma vs metastatic kidney cancer).
Patients receive denileukin diftitox IV over 1 hour on days 1-5, 21-25, 42-46, and 63-67. Treatment repeats every 84 days (12 weeks) for up to a maximum total of 5 courses in the absence of disease progression, autoimmune ocular toxicity attributable to denileukin diftitox, or any other unacceptable toxicity. At any time during therapy, patients achieving a complete response receive 1 additional course of therapy after the complete response.
PROJECTED ACCRUAL: A total of 10-96 patients (5-48 per stratum) will be accrued for this study within 3-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||July 2006|
- Clinical response
- Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082914
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|