Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00005069
First received: April 6, 2000
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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
Kidney Cancer
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: January 2000
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005069

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005069     History of Changes
Other Study ID Numbers: 99-107, CDR0000067674, NCI-T99-0105
Study First Received: April 6, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014