6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00003390|
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : June 21, 2013
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 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: irofulven||Phase 2|
OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene (HMAF) in patients with metastatic renal cell carcinoma. II. Investigate the safety of HMAF given to this patient population.
OUTLINE: Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed after every 2 treatment courses.
PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 6-19 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma|
|Study Start Date :||June 1998|
|Study Completion Date :||August 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003390
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||William Berg, MD||Sanofi|