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O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00669669
Recruitment Status : Active, not recruiting
First Posted : April 30, 2008
Results First Posted : December 28, 2018
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma
Gliosarcoma
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carmustine
Biological: Filgrastim
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Drug: O6-Benzylguanine
Drug: Plerixafor
Radiation: Proton Beam Radiation Therapy
Drug: Temozolomide
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy, Autologous Stem Cell Transplant)
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3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT

Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Carmustine: Given IV

Filgrastim: Given SC

In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT

Laboratory Biomarker Analysis: Correlative studies

O6-Benzylguanine: Given IV

Plerixafor: Given SC

Proton Beam Radiation Therapy: Undergo proton beam radiation therapy

Temozolomide: Given PO

Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
To late to start treatment             1
Arm/Group Title Treatment (Chemotherapy, Autologous Stem Cell Transplant)
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3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT

Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Carmustine: Given IV

Filgrastim: Given SC

In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT

Laboratory Biomarker Analysis: Correlative studies

O6-Benzylguanine: Given IV

Plerixafor: Given SC

Proton Beam Radiation Therapy: Undergo proton beam radiation therapy

Temozolomide: Given PO

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
  83.3%
More than one race
1
   8.3%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants Dose-limiting Toxicity (DLT)
Hide Description Defined as any grade 4 nonhematopoietic toxicity that is likely related to the investigational procedures (Part I)
Time Frame Up to 6 weeks after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy, Autologous Stem Cell Transplant)
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See Detailed Description

3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT

Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Carmustine: Given IV

Filgrastim: Given SC

In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT

Laboratory Biomarker Analysis: Correlative studies

O6-Benzylguanine: Given IV

Plerixafor: Given SC

Proton Beam Radiation Therapy: Undergo proton beam radiation therapy

Temozolomide: Given PO

Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   9.1%
2.Primary Outcome
Title Number of Participants With Retrovirus or Leukemia
Hide Description Replication competent retrovirus or diagnosis of leukemia
Time Frame Up to 2 years after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy, Autologous Stem Cell Transplant)
Hide Arm/Group Description:

See Detailed Description

3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT

Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Carmustine: Given IV

Filgrastim: Given SC

In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT

Laboratory Biomarker Analysis: Correlative studies

O6-Benzylguanine: Given IV

Plerixafor: Given SC

Proton Beam Radiation Therapy: Undergo proton beam radiation therapy

Temozolomide: Given PO

Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Response Rate
Hide Description Proportion of patients with reduction in tumor burden of a predefined amount
Time Frame Up to 15 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response
Hide Description From the onset of temozolomide to the date at which unequivocal disease progression, assessed up to 15 years
Time Frame Up to 15 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants That Survived
Hide Description From the first day of treatment until death, assessed up to 15 years
Time Frame Up to 15 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Progression
Hide Description From the first day of treatment until unequivocal progression is documented, assessed up to 15 years
Time Frame Up to 15 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Gene Transfer Efficiency and in Vivo Selection
Hide Description Assessed by gene marking in peripheral blood and marrow
Time Frame Up to 15 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Number of Participants With Chemoprotection
Hide Description assessed by the ability to increase the Temozolomide dose beyond 472 mg/m^2
Time Frame Up to 15 years
Outcome Measure Data Not Reported
Time Frame Adverse Events are collected until through study completion on average 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Chemotherapy, Autologous Stem Cell Transplant)
Hide Arm/Group Description

See Detailed Description

3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal IMRT

Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Carmustine: Given IV

Filgrastim: Given SC

In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo autologous in vitro-treated peripheral blood stem cell transplant

Intensity-Modulated Radiation Therapy: Undergo 3D conformal IMRT

Laboratory Biomarker Analysis: Correlative studies

O6-Benzylguanine: Given IV

Plerixafor: Given SC

Proton Beam Radiation Therapy: Undergo proton beam radiation therapy

Temozolomide: Given PO

All-Cause Mortality
Treatment (Chemotherapy, Autologous Stem Cell Transplant)
Affected / at Risk (%)
Total   1/11 (9.09%)    
Hide Serious Adverse Events
Treatment (Chemotherapy, Autologous Stem Cell Transplant)
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Chemotherapy, Autologous Stem Cell Transplant)
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Heme & Lymphatics   11/11 (100.00%)  162
Cardiac disorders   
Cardiovascular   2/11 (18.18%)  8
Ear and labyrinth disorders   
HEENT   5/11 (45.45%)  57
Endocrine disorders   
Endocrine   2/11 (18.18%)  7
Gastrointestinal disorders   
Digestive   7/11 (63.64%)  18
General disorders   
General   5/11 (45.45%)  8
Metabolism and nutrition disorders   
Metabolic & Nutritional   11/11 (100.00%)  155
Musculoskeletal and connective tissue disorders   
Musculoskeletal   6/11 (54.55%)  15
Nervous system disorders   
Nervous   8/11 (72.73%)  43
Reproductive system and breast disorders   
Urogenital   4/11 (36.36%)  9
Respiratory, thoracic and mediastinal disorders   
Respiratory   2/11 (18.18%)  7
Skin and subcutaneous tissue disorders   
Skin & Appendages   7/11 (63.64%)  12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials.Gov FHCRC Office
Organization: Fred Hutch Cancer Research Center
Phone: 2066674520
EMail: ct.gov@fredhutch.org
Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00669669    
Other Study ID Numbers: 2000.00
NCI-2013-00701 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8357
2000.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: April 29, 2008
First Posted: April 30, 2008
Results First Submitted: November 7, 2018
Results First Posted: December 28, 2018
Last Update Posted: December 16, 2019