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Trial record 43 of 230 for:    "Anaplastic oligodendroglioma"

FR901228 in Treating Patients With Recurrent High-Grade Gliomas

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ClinicalTrials.gov Identifier: NCT00085540
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : November 15, 2016
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Intervention: Drug: depsipeptide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Phase 1 Dose Escalation - Romidepsin

Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose escalation two dose levels:

Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2

Pharmacokinetics

depsipeptide: Given IV

Phase 2 Dose From Phase 1 - Romidepsin

Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Romidepsin (depsipeptide): 13.3mg/m2

depsipeptide: Given IV


Participant Flow:   Overall Study
    Phase 1 Dose Escalation - Romidepsin   Phase 2 Dose From Phase 1 - Romidepsin
STARTED   8   42 
COMPLETED   8   40 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                1 
Protocol Violation                0                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.
two patients were removed from the analysis due to one withdrawing consent and one was deemed ineligible.

Reporting Groups
  Description
Phase 1 Dose Escalation - Romidepsin

Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dose escalation two dose levels:

Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2

Pharmacokinetics

depsipeptide: Given IV

Phase 2 Dose From Phase 1 - Romidepsin

Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Romidepsin (depsipeptide): 13.3mg/m2

depsipeptide: Given IV

Total Total of all reporting groups

Baseline Measures
   Phase 1 Dose Escalation - Romidepsin   Phase 2 Dose From Phase 1 - Romidepsin   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   40   48 
Age 
[Units: Years]
Median (Full Range)
 52 
 (44 to 57) 
 55 
 (37 to 79) 
 54 
 (37 to 79) 
Gender 
[Units: Participants]
Count of Participants
     
Female      3  37.5%      10  25.0%      13  27.1% 
Male      5  62.5%      30  75.0%      35  72.9% 
Karnofsky Performance Status Scale (KPS) [1] 
[Units: Units on a scale]
     
90-100   4   19   23 
60-80   4   21   25 
[1] Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
Histology 
[Units: Participants]
     
Anaplastic glioma   2   5   7 
Gliobastoma   6   35   41 
Prior Radiotherapy 
[Units: Participants]
 8   40   48 
Prior chemotherapy regimens 
[Units: Number of chemotherapy regimens]
Median (Full Range)
 1 
 (1 to 2) 
 1 
 (1 to 3) 
 1 
 (1 to 3) 


  Outcome Measures

1.  Primary:   Number of Participants With Dose-limiting Toxicities Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I)   [ Time Frame: First 4 weeks of treatment ]

2.  Primary:   6 Months Progression-free Survival (Phase II)   [ Time Frame: At 6 months ]

3.  Secondary:   Response Rate Associated With Depsipeptide Therapy (Phase II)   [ Time Frame: Up to 2 years ]


  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
Dose escalation was terminated after 2 dose levels because PK parameters of romidepsin in pts receiving EIAEDs were similar to those reported in Adults not receiving CYP34A inducing drugs, we wanted to avoid the expected dose limiting toxicity.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Howard Fine, MD
Organization: Adult Brain Tumor Consortium (ABTC)
phone: 410-955-8837
e-mail: jfisher@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085540     History of Changes
Obsolete Identifiers: NCT00103909
Other Study ID Numbers: NCI-2012-02596
NABTC-0303
U01CA062399 ( U.S. NIH Grant/Contract )
CDR0000370817 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: June 10, 2004
First Posted: June 11, 2004
Results First Submitted: September 23, 2016
Results First Posted: November 15, 2016
Last Update Posted: January 2, 2017