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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00082914 |
Purpose
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) |
Biological: 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000361715, NCI-04-C-0134 |
| Study First Received: | May 14, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00082914 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent renal cell cancer stage IV renal cell cancer recurrent melanoma stage IV melanoma |
|
Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms by Site Urologic Diseases Sensory System Agents Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Kidney Diseases Analgesics |
Neoplasms by Histologic Type Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Interleukin-2 Analgesics, Non-Narcotic Denileukin diftitox Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Central Nervous System Agents Neoplasms, Glandular and Epithelial |