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Trial record 9 of 39 for:    Von Hippel-Lindau Disease (VHL)

17AAG to Treat Kidney Tumors in Von Hippel-Lindau Disease

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ClinicalTrials.gov Identifier: NCT00088374
Recruitment Status : Completed
First Posted : July 26, 2004
Results First Posted : September 29, 2011
Last Update Posted : July 27, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hippel-Lindau Disease
Kidney Cancer
Interventions: Drug: 17 allylamino-17-demethoxygeldanamycin
Drug: 18 FDG (Fludeoxyglucose 18F)
Drug: [15-O] H2O
Drug: EPL diluent

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The accrual ceiling for this study is 25 patients. With an expected accrual of 10-12 patients per year, we expect to complete the accrual within 2-3 years.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
VHL Associated Renal Tumors 17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.

Participant Flow:   Overall Study
    VHL Associated Renal Tumors
STARTED   9 
COMPLETED   7 
NOT COMPLETED   2 
patient did not receive any 17AAG                1 
patient received <1 cycle only of 17AAG                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VHL Associated Renal Tumors 17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.

Baseline Measures
   VHL Associated Renal Tumors 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   8 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.32  (10.82) 
Gender 
[Units: Participants]
 
Female   3 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures

1.  Primary:   Number of Participants With a Renal Tumor Response   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Participants With a Non-renal Tumor Response   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   The Number of Participants With Adverse Events   [ Time Frame: 1 yr, 364 days ]

4.  Secondary:   The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake   [ Time Frame: Baseline and at 12 weeks ]

6.  Secondary:   Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor   [ Time Frame: Baseline and during therapy (12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study did not meet accrual.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William M. Linehan, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-6353
e-mail: linehanm@mail.nih.gov


Publications:

Responsible Party: William M. Linehan, M.D., National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00088374     History of Changes
Obsolete Identifiers: NCT00089375
Other Study ID Numbers: 040238
04-C-0238 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
040238 ( Other Identifier: Clinical Center (CC), National Institutes of HEalth (NIH) )
First Submitted: July 23, 2004
First Posted: July 26, 2004
Results First Submitted: May 24, 2011
Results First Posted: September 29, 2011
Last Update Posted: July 27, 2012