Memorial Sloan-Kettering Cancer Center
New York, 10021, United States
NCT Number: NCT00003390
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
New York, 10021, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Memorial Sloan Kettering Cancer Center
Other
A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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