A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
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|ClinicalTrials.gov Identifier: NCT01483690|
Recruitment Status : Terminated (Toxicity)
First Posted : December 1, 2011
Last Update Posted : November 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Precursor B-Cell Lymphoblastic Leukemia Precursor T-Cell Lymphoblastic Leukemia||Drug: Decitabine Drug: Vorinostat Drug: Vincristine Drug: Dexamethasone Drug: Mitoxantrone Drug: Pegaspargase Drug: Methotrexate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2015|
- suberoylanilide hydroxamic acid (SAHA)
- Vincasar PFS
- vincristine sulfate
- Dexamethasone Intensol
- dexamethasone acetate
- dexamethasone sodium phosphate
- 8 mg for patients age 1-1.99
- 10 mg for patients age 2-2.99
- 12 mg for patients 3-8.99 years of age
- 15 mg for patients >9 years of age
Given intrathecally to all patients the dose defined by age below.
CNS 1 or 2 patients get doses on day 8, 22 and 35 and CNS 3 patients should get doses on day 8, 15, 22, 29 and 35
- Number of participants with adverse events. [ Time Frame: 6 weeks ]To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.
- Disease response rate after treatment. [ Time Frame: 6 weeks ]The study will assess whether the patient's acute lymphoblastic leukemia goes into remission after treatment.
- Gene-specific methylation profiles [ Time Frame: 2 years ]To assess the biologic activity of decitabine by comparing pre and post-treatment marrow samples for global and gene-specific methylation profiles using HELP and methylation-specific PCR.
- Global histone acetylation and histone modifications [ Time Frame: 2 years ]To assess the biological activity of vorinostat by comparing pre- and post-treatment blood and bone marrow samples for global histone acetylation (using acetyl-H3 Western blotting), and for gene-specific histone modifications (using H3K9/14Ac ChIP-chip and ChIP-qPCR).
- Gene expression profiles [ Time Frame: 2 years ]To determine the impact of combined epigenetic therapy on the expression of epigenetically-regulated genes by comparing pre and post-treatment marrow samples for gene expression profiles (using microarrays), and correlating these with the methylation and histone modification assays.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483690
Show 28 Study Locations
|Study Chair:||Michael Burke, MD||Medical College of Wisconsin|