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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005069 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: arsenic trioxide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma |
Study Start Date: | April 2000 |
OBJECTIVES: I. Evaluate the efficacy of arsenic trioxide in patients with metastatic renal cell cancer. II. Determine the safety of this regimen in this patient population.
OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for 5 days. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer Bidimensionally measurable disease No brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal ALT or AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN (no greater than 1.95 mg/dL at MSKCC) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study No other prior malignancy unless curatively treated and disease free for the past 5 years and considered low risk for recurrence
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Robert J. Motzer, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067674, MSKCC-99107, NCI-T99-0105 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005069 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Arsenic trioxide Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |