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A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William Berg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sanofi

Authority:

United States: Federal Government

Study ID:

CDR0000066388

NCT ID:

NCT00003390

Start Date:

June 1998

Completion Date:

August 2004

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021