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
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Tracking Information | ||||
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
35 | |||
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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) ) |
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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 |
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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 |