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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082914 |
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 | Intervention | Phase |
---|---|---|
Kidney Cancer Melanoma (Skin) |
Drug: denileukin diftitox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000361715, NCI-04-C-0134 |
Study First Received: | May 14, 2004 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00082914 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage IV renal cell cancer recurrent melanoma stage IV melanoma |
Urogenital Neoplasms Renal cancer Kidney cancer Urologic Neoplasms Recurrence Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Urologic Diseases Interleukin-2 |
Kidney Neoplasms Denileukin diftitox Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neuroepithelioma Nevus Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Nevi and Melanomas Analgesics Peripheral Nervous System Agents Central Nervous System Agents |