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Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer



Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer

For Condition: recurrent renal cell cancer,childhood kidney/urinary cancer,stage 4 renal cell cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic renal cell cancer - Bidimensionally measurable disease - No brain metastases --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertMotzer,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000067674;  MSKCC-99107,NCI-T99-0105
Study Start Date: April 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005069

Other Stage 4 Renal Cell Cancer Studies:
1. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer

2. ZD 1839 in Treating Patients With Metastatic Kidney Cancer

3. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

4. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer

5. Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer

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