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6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003390
First received: November 1, 1999
Last updated: June 20, 2013
Last verified: May 2000

November 1, 1999
June 20, 2013
June 1998
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Complete list of historical versions of study NCT00003390 on ClinicalTrials.gov Archive Site
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6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer
A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Kidney Cancer
Drug: irofulven
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2004
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DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma and evidence of metastatic disease Bidimensionally measurable disease No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over 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 within normal range ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine within 1.5 times ULN AND Creatinine clearance at least 50 mL/min Other: Not pregnant or lactating Fertile patients must use effective contraception No prior malignancy within 5 years and at low risk for recurrence Must have undergone potentially curative therapy for prior malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biological therapy and recovered Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since hormone therapy and recovered Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003390
CDR0000066388, MSKCC-98009, MSKCC-98007, NCI-T97-0119
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: William Berg, MD Sanofi
National Cancer Institute (NCI)
May 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP