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Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)


I. Determine the objective response rate to bryostatin 1 in patients with advanced renal
cell carcinoma.

II. Assess the toxicities of this treatment regimen in this patient population. III.
Determine the time to disease progression in patients receiving this treatment regimen.

IV. Determine the overall survival of this patient population treated with this regimen.


Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every
4 weeks in the absence of unacceptable toxicity or disease progresssion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

Inclusion Criteria


- Histologically confirmed metastatic renal cell carcinoma

- Bidimensionally measurable disease

- Clear evidence of progression if only site of measurable disease is within previous
radiation port

- Previously irradiated brain metastases allowed, if not life threatening, symptoms
controlled for 3 months, and not requiring corticosteroids


- Age: 18 and over

- Performance status: ECOG 0-1

- Life expectancy: Greater than 3 months

- WBC at least 3,000/mm3

- Platelet count at least 100,00/mm3

- Bilirubin no greater than 1.5 mg/dL

- Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 1 month before, during, and for
3 months after study

- No active bacterial or viral infection

- No serious underlying medical condition that would interfere with compliance

- No other malignancy within the past 5 years except basal cell carcinoma of the skin

- No dementia or altered mental status that would prevent informed consent


- No more than 1 prior therapy with biologic response modifiers

- No prior chemotherapy for advanced disease

- No other concurrent chemotherapy

- No concurrent steriods (except topical use)

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

- At least 4 weeks since major surgery (including nephrectomy)

- No other concurrent experimental agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Naomi S. Balzer-Haas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 1999

Completion Date:

Related Keywords:

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



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
South Jersey Hospital - Millville Millville, New Jersey  08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Community Medical Center Toms River, New Jersey  08755
St. Francis Medical Center Trenton, New Jersey  08629
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Hunterdon Regional Cancer Center Flemington, New Jersey  08822
Riverview Medical Center Red Bank, New Jersey  07701
Kimball Medical Center Lakewood, New Jersey  08701
North Penn Hospital Lansdale, Pennsylvania  19446-1200
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Pinnacle Health Hospitals Harrisburg, Pennsylvania  17105-8700
Conemaugh Memorial Hospital Johnstown, Pennsylvania  15905
Pottstown Memorial Regional Cancer Center Pottstown, Pennsylvania  19464
Bon Secours-Holy Family Health System Altoona, Pennsylvania  16602
Saint Mary Medical Center Langhorne, Pennsylvania  19047