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A Phase II Trial of Bryostatin-1 in Hypernephroma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

A Phase II Trial of Bryostatin-1 in Hypernephroma

OBJECTIVES: I. Determine the response rates in patients with progressive hypernephroma
treated with bryostatin 1. II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours on days
1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. For patients with stable or
responding disease after completion of course 2, treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 12-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven progressive hypernephroma Bidimensionally
measurable disease with documented progression within 2 months prior to study entry Sites
of measurable or evaluable disease must be outside prior radiation ports No active
symptomatic CNS disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy:
Greater than 3 months Hematopoietic: Granulocyte count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.17 mg/dL SGOT or SGPT less
than 2.5 times normal Renal: Creatinine less than 1.70 mg/dL Other: No other prior or
concurrent malignancy except adequately treated cone biopsied carcinoma in situ of the
cervix or basal cell or squamous cell skin cancer No severe or uncontrolled nonmalignant
systemic disease that would make the patient a poor medical risk No uncontrolled active
infection Not pregnant or nursing Fertile patients must use effective contraception during
and for 4 weeks after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since
prior endocrine therapy or steroids and recovered No concurrent systemic steroids
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and
recovered No concurrent radiotherapy Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Adrian L. Harris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oxford Radcliffe Hospital


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

July 2006

Related Keywords:

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