Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI MSKCC-98009 MSKCC-98007, NCI-T97-0119

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.

Entry Criteria

Disease Characteristics:

Histologically confirmed renal cell carcinoma and evidence of metastatic
disease

Bidimensionally measurable disease

No active brain metastases

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
   

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

Projected Accrual

Approximately 12-37 patients will be accrued for this study within 6-19 months.

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

William Berg, MD, Protocol chair(Contact information may not be current)		Ph: 908-243-6000; 800-981-2491

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