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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute, Myelodysplastic Syndromes

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of a combination of Sorafenib and Vorinostat administered to patients with poor-risk AML, or MDS with >10% blasts.

Outcome Time Frame:

Baseline through cycle 3

Safety Issue:

Yes

Principal Investigator

Hamid Sayar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

0902-08; IUCRO-0234

NCT ID:

NCT00875745

Start Date:

April 2009

Completion Date:

April 2013

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Promyelocytic, Acute
  • Myelodysplastic Syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Promyelocytic, Acute
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289