Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00003968

Recruitment Status : Completed

First Posted : May 3, 2004

Last Update Posted : February 8, 2013

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Tracking Information

First Submitted Date ^ICMJE

November 1, 1999

First Posted Date ^ICMJE

May 3, 2004

Last Update Posted Date

February 8, 2013

Study Start Date ^ICMJE

June 1999

Actual Primary Completion Date

December 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003968 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Cancer

Intervention ^ICMJE

Drug: bryostatin 1

Study Arms

Experimental: Arm I

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.

Intervention: Drug: bryostatin 1

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Study Completion Date

Not Provided

Actual Primary Completion Date

December 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00003968

Other Study ID Numbers ^ICMJE

NCI-2012-02303
FCCC-99012
NCI-T99-0002
CDR0000067169 ( Registry Identifier: PDQ (Physician Data Query) )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

National Cancer Institute (NCI)

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Naomi S. Balzer-Haas, MD

Fox Chase Cancer Center

PRS Account

National Cancer Institute (NCI)

Verification Date

January 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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