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Myelodysplastic SyndromesPhase 1/2GFMVOR2007NCT00776503

Vorinostat and Low Dose Cytarabine for High Risk Myelodysplasia

A Phase 1/2 study testing VORINOSTAT in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
VORINOSTAT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
14 sitesFrance
Study dates
May 2008to Nov 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following criteria to participate in the study:
  • Patient has MDS including the following FAB sub-types: refractory anemia with blast excess (RAEB) ,transformed refractory anemia with blast excess (RAEB-t) and non proliferative Chronic MyeloMonocytic Leukemias (WBC below 13G/l).
  • Patient has a IPSS score > 1. 5 (INT-2 and high risk categories).
  • Patient must have been previously treated with demethylating agents (including Azacitidine and Decitabine) and :
  • failed to respond or
  • progress after treatment.
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  • Patient is male or female, and ≥ 18 years of age on day of signing informed consent.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (See Appendix 6.1).
  • Patient has recovered from toxicities due to prior therapy (less than grade 2) except for cytopenia
  • Patient must have adequate organ function as indicated by the following laboratory values: serum creatinine <2mg/dl; total bilirubin <2,5ULN; AST<2,5ULN, ALT<2,5ULN, PAL<5ULN
  • Patient is known to not be refractory to platelet transfusions.
  • Female patient of childbearing potential has a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of vorinostat and or Ara-C . Female patient is not actively breastfeeding at the time of study entry.
  • Female patient is either post-menopausal, free from menses for > 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from becoming pregnant throughout the study, starting with Visit 1.
  • Male patient agrees to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving vorinostat and for 1 month post study.
  • Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
  • Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.
  • Patient is able to swallow capsules.

Who cannot join

  • Patient had prior treatment with an HDAC inhibitor (e.g., depsipeptide or NSC-630176, MS 275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc). Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period.
  • Patient has been previously treated with low dose (20 mg/m2 SC daily) Ara-C for MDS within 3 months of beginning this study.
  • Patient has active and uncontrolled infection
  • Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.
  • Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
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  • Patient has clinically active hepatitis B or hepatitis C infection.
  • Patient has a known allergy or hypersensitivity to any component of vorinostat or Ara-C.
  • Patient with a "currently active" second malignancy, other than nonmelanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse.
  • Patient has received growth factors such as epoetin alfa (EPO) or granulocyte colony-stimulating factor (G-CSF) or has received non cytotoxic agents (including low dose oral chemotherapy) in the 30 days before inclusion. In case of previous cytotoxic treatment, an interval of 3 months is required.
  • Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤ 10 mg/day prednisone during the 4 weeks prior to the start of the study drugs
  • Patients with clinical evidence of CNS leukemia.
  • Patient has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drugs.
  • Patient is unable to take and/or tolerate oral medications on a continuous basis.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Hôpital de la Durance

    Avignon, 84902

  • Hopital Avicenne

    Bobigny, 93009

  • CH René Dubos

    Cergy-Pontoise, 95303

  • Hematology Dpt, Hôpital Sud Francilien

    Corbeil-Essonnes, 91100

  • CHU Grenoble

    Grenoble, 38043

  • Hôpital Edouard Heriot, dpt Hématologie Clinique

    Lyon, 69437

  • Hematology Dpt, Institut Paoli Calmettes

    Marseille, 13009

  • Hematology Dpt, Hopital de l'Hotel Dieu

    Nantes, 44093

  • Hematology Dpt, Hopital Saint Louis

    Paris, 75475

  • Hematology Dpt, Hopital Cochin

    Paris, 75679

  • Centre Henri Bequerel

    Rouen, 76038

  • Centre René Huguenin

    Saint-Cloud, 92210

  • Hematology Dpt, Hopital Haute Pierre

    Strasbourg, 67098

  • Hematology Dpt, Hopital Purpan

    Toulouse, 40031

Other trials in France

About this study

Official title: A Phase I/II Study of Vorinostat in Combination With Low Dose Ara-C for Patients With Intermediate-2 or High Risk Myelodysplastic Syndromes

The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes.

Read the detailed description

This is a multi-center, open-label, non-randomized, Phase I/II study. Patients will be treated either with arm A or B dosing schedules which contain increasing durations of exposure to vorinostat. LD Ara-C will be administered once daily, subcutaneously(SC), at 10 mg/m² in Cycle 1 and escalated to 20 mg/m² daily in Cycle 2 and above for 14 out of 28 days. Oral vorinostat will be administered as 400 mg, once daily either sequentially(Arm A) or concurrently (Arm B) with LD Ara-C in Dose Level #1 for 7 days, Dose Level #2 for 10 days, or Dose Level #3 for 14 days out of each 28-day cycle. Patients who do not have disease progression and who continue to meet eligibility criteria may receive up to 3 additional 28-day cycles of treatment.

Being tested
VORINOSTAT
Keywords
Epigenetic, Myelodysplasia, Cytarabine
Medical subject headings
Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VORINOSTATDrug

    Also called SAHA, ZOLINZA

    vorinostat; 400mg once daily; increasing duration (7-10-14 days)

Study groups in NCT00776503
Study groupRoleWhat they receive
BExperimentalCytarabine 10mg/m2 day 1-14 Vorinostat 400mg/d day 1-(7 or 10 or 14)
Receives: Drug: VORINOSTAT
AExperimentalCytarabine 10mg/m2 day 1-14 Vorinostat 400mg/d day 15-(21 or 24 or 28)
Receives: Drug: VORINOSTAT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the Maximum tolerated dose of the association

    Measured: After 1 cycle of treatment

Secondary outcomes (1)

  1. To determine the clinical activity of this association

    Measured: after 3 cycles of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00776503
Sponsor's protocol ID
GFM VOR 2007-01
Acronym
GFMVOR2007
Status last verified
Nov 2011
First submitted
20 Oct 2008
Last updated
20 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Prebet T, Braun T, Beyne-Rauzy O, Dreyfus F, Stammatoullas A, Wattel E, Ame S, Raffoux E, Delaunay J, Charbonnier A, Ades L, Fenaux P, Vey N. Combination of vorinostat and low dose cytarabine for patients with azacitidine-refractory/relapsed high risk myelodysplastic syndromes. Leuk Res. 2014 Jan;38(1):29-33. doi: 10.1016/j.leukres.2013.07.023. Epub 2013 Aug 13.

    PubMed 23953882

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VORINOSTAT in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the Maximum tolerated dose of the association (time frame: After 1 cycle of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00776503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.

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