Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
This study is ongoing, but not recruiting participants.
Sponsor:
Indiana University School of Medicine
Collaborator:
Bayer
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00875745
First received: April 2, 2009
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to test the safety of sorafenib and vorinostat when given together to see what effects (good and bad) it has on the patient and their acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the highest dose of sorafenib and vorinostat that can be given together without causing severe side effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Myelodysplastic Syndromes |
Drug: Sorafenib-Vorinostat |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I, Open-label, Dose-escalation Study of the Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) |
Resource links provided by NLM:
Further study details as provided by Indiana University:
Primary Outcome Measures:
- Determine the maximum tolerated dose of a combination of Sorafenib and Vorinostat administered to patients with poor-risk AML, or MDS with >10% blasts. [ Time Frame: Baseline through cycle 3 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate response and the duration of response to this combination targeted therapy [ Time Frame: Baseline through Cycle 3 ] [ Designated as safety issue: No ]
- Evaluate the toxicity of the combination of Sorafenib and Vorinostat in patients receiving this therapy [ Time Frame: Baseline through Cycle 3 ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sorafenib-Vorinostat
This is a single-arm, non-randomized feasibility and safety Phase I trial of a combination of Sorafenib and Vorinostat, both administered orally.
|
Drug: Sorafenib-Vorinostat
Patients will be entered in successive cohorts. The first cohort will receive Sorafenib at 400 mg bid (800 mg daily) and Vorinostat at 100 mg bid (200 mg daily).
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have a diagnosis of AML (> 20% myeloid blasts in the peripheral blood or bone marrow) or MDS with > 10% myeloid blasts in the bone marrow. Patients with Acute Promyelocytic Leukemia (APL) must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide.
The patients must have one of the following criteria:
- Age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
- Age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
- Age of 70 years or older with relapsed or refractory disease
- The patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
- Patients must have an ECOG (Zubrod) performance status of 0-2
- Patients must be able to take and tolerate oral medications
- Patients must have adequate organ function as specified in the protocol.
- Patients not on anti-coagulation must have an INR < 1.5 and a PTT within normal limits.
Exclusion Criteria:
- Pregnant women or nursing mothers are not eligible for this trial.
- Patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
- Patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. See protocol for listing.
- Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging
- Patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875745
Locations
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
Sponsors and Collaborators
Indiana University School of Medicine
Bayer
Investigators
| Principal Investigator: | Hamid Sayar, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
No publications provided
| Responsible Party: | Indiana University ( Indiana University School of Medicine ) |
| ClinicalTrials.gov Identifier: | NCT00875745 History of Changes |
| Other Study ID Numbers: | 0902-08; IUCRO-0234 |
| Study First Received: | April 2, 2009 |
| Last Updated: | October 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Promyelocytic, Acute Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Vorinostat Sorafenib Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013