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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00331617 |
RATIONALE: Biological therapies, such as aldesleukin, may stimulate the white blood cells to kill tumor cells. Giving aldesleukin at high doses may kill more tumor cells.
PURPOSE: This phase II trial is studying how well high-dose aldesleukin works in treating patients with metastatic melanoma or metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer Melanoma (Skin) |
Drug: aldesleukin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Studies on the Mechanism of Action of High-Dose IL-2 in Metastatic Melanoma and Renal Cell Cancer |
Estimated Enrollment: | 245 |
Study Start Date: | March 2006 |
OBJECTIVES:
OUTLINE: This is a pilot study.
Patients receive high-dose aldesleukin IV over 15 minutes 3 times daily for 4 days. Approximately 7-10 days later, patients receive additional aldesleukin as above 3 times daily for 4 days (course 1). Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 245 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma or renal cell cancer
PATIENT CHARACTERISTICS:
FEV_1 or vital capacity > 65% of predicted
LVEF ≥ 45%
PRIOR CONCURRENT THERAPY:
No concurrent systemic or inhaled steroids
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Patient Recruitment 866-820-4505 |
Principal Investigator: | James C. Yang, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000473925, NCI-06-C-0115, NCI-P6910 |
Study First Received: | May 30, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00331617 |
Health Authority: | Unspecified |
stage IV melanoma stage IV renal cell cancer recurrent melanoma recurrent renal cell cancer |
Urogenital Neoplasms Renal cancer Kidney cancer Urologic Neoplasms Recurrence Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Urologic Diseases |
Kidney Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neuroepithelioma Nevus Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Site Neoplasms by Histologic Type Anti-Retroviral Agents |
Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue Nevi and Melanomas Antiviral Agents Pharmacologic Actions |