Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma
arsenic trioxide
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: January 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps