Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003968
• Other study ID #: NCI-2012-02303
• Secondary ID: FCCC-99012NCI-T9
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 7, 2013
• Start date: June 1999

Study information

• Verified date: January 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Description:

OBJECTIVES:

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.

OUTLINE:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• bryostatin 1

Locations

Country	Name	City	State
United States	Bon Secours-Holy Family Health System	Altoona	Pennsylvania
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	Conemaugh Memorial Hospital	Johnstown	Pennsylvania
United States	Kimball Medical Center	Lakewood	New Jersey
United States	Saint Mary Medical Center	Langhorne	Pennsylvania
United States	North Penn Hospital	Lansdale	Pennsylvania
United States	South Jersey Hospital - Millville	Millville	New Jersey
United States	Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Community Medical Center	Toms River	New Jersey
United States	St. Francis Medical Center	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,