Know Cancer

or
forgot password

Phase I Dose Escalating Trial of VELCADE (PS-341) in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Phase I Dose Escalating Trial of VELCADE (PS-341) in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia


Inclusion Criteria:



- Patients must be 18 years or older.

- Unequivocal histologic diagnosis of AML (>20% blasts in the blood and/or bone marrow
based on the WHO and/or FAB classifications as described in Appendix 9.3), excluding
M3 (acute promyelocytic leukemia).

- For patients less than 60, disease must have previously achieved CR and then relapsed
(>20% blasts in the blood and/or bone marrow based on the WHO and/or FAB
classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic
leukemia).). These patients must have a period of remission of >3 months (beginning
with the time when the ANC >1,500/ul, platelets >100,000/ul and < 5% marrow blasts
are present).

- Patients 60 years of age or older may have relapsed disease or may have previously
untreated AML (>20% blasts in the blood and/or bone marrow based on the WHO and/or
FAB classifications as described in Appendix 9.3), excluding M3 (acute promyelocytic
leukemia).

- Patients may have prior myelodysplasia. Patients may have prior treatment for
myelodysplasia.

- Patients may have had prior chemotherapy for another malignancy or an antecedent
hematologic disorder such as myelodysplasia.

- Patients must have an ECOG performance status 0-3.

- Patients must have all of the following pretreatment laboratory values within 21 days
of enrollment: total bilirubin <= 1.5 X the upper limit of normal (ULN), ALT and AST
<= 2.5 X the ULN, creatinine <= 2.0 mg/dl.

- Male patients need to use an appropriate method of barrier contraception during the
study.

- Female patients must be post-menopausal, surgically sterilized, or willing to use
acceptable methods of birth control (i.e. a hormonal contraceptive, an intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Patients must give voluntary written informed consent before performance of any
study-related procedure not part of normal medical care.

Exclusion Criteria:

- If less than 60 years old, patient has received chemotherapy within the last three
months (90 days).

- Patients with untreated AML < 60 years old.

- Other active malignancy (with the exception of basal and squamous cell skin cancer)
at the time of study entry.

- Patient has hypersensitivity to boron or mannitol

- Severe pulmonary or cardiac disease.

- History of congestive heart failure or ejection fraction < 40%.

- Patient had a myocardial infarction within 6 months of enrollment or has New York
Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities.

- Patients with M3 AML (acute promyelocytic leukemia) by FAB or WHO as described in
9.3.

- Patients with HIV infection.

- Patients with known active hepatitis B or C.

- Patients with known central nervous system leukemia. A lumbar puncture is not
required unless CNS involvement is clinically suspected.

- Patients who are pregnant or breast feeding.

- Patients with major surgery within the 4 weeks prior to trial enrollment.

- Patients with ³ Grade 2 peripheral neuropathy within 21 days before enrollment.

- Patients with an uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, or cardiac arrhythmia. If the condition becomes controlled, the patient
may become eligible.

- Patients with any serious medical or psychiatric illness that could, in the
investigator's opinion, potentially interfere with the completion of treatment
according to this protocol.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Philip C Amrein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

03-103

NCT ID:

NCT00505700

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Leukemia
  • acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Beth Israel/ Deaconess Medical CenterBoston, Massachusetts  02115