Experimental medicine, Carfilzomib and chemotherapy treatment for newly diagnosed acute lymphoblastic leukemia or lymphoma

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"Study looking at side effects and best dose of the study medicine, carfilzomib with approved chemotherapy for treatment of leukemia patients"
Age:
18 to 64 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
leukemia, lymphoma, cancer
Type:
Drug study, Phase 1
Investigator:
Description
This study looks at the side effects and best dose of the study medicine, carfilzomib, which has not yet been approved by the Food and Drug Administration (FDA) for use in this type particular type of cancer. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

This study will also use Hyper-CVAD chemotherapy. Hyper-CVAD comes from the initials of the drugs used: cyclophosphamide, vincristine, doxorubicin (which is also called Adriamycin), dexamethasone (a steroid). Hyper comes from the word hyperfractionated which means you have more than one treatment of the same drug given in a day. Hyper-CVAD treatment also includes cytarabine and methotrexate. All of these drugs are FDA approved and are used commonly for your type of cancer. Chemotherapy works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Giving carfilzomib with combination chemotherapy may kill more cancer cells.
This study requires
History and Physical
Blood samples
Urine test
Electrocardiogram (ECG)
Echocardiogram (ECHO)
Chest X- ray
Bone marrow aspiration or biopsy
Study Drug/Chemotherapy administration
Who can participate?
Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Newly diagnosed acute lymphoblastic leukemia/lymphoma

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (3 if it is directly disease related and is expected to get better if the acute lymphoblastic leukemia/lymphoma [ALL] is under control)

- Left ventricular ejection fraction (LVEF) > 40%

- Total bilirubin =< 3 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.5 x upper limit of normal

- Creatinine clearance (CrCl) >= 45 mL/minute within 7 days prior to enrollment either measured or calculated using a standard formula (eg, Cockcroft and Gault); in cases that creatinine clearance cannot be measured accurately, 24 hour urine can be used

- Disease free of other malignancies beside the ALL at the time of the study

- Male subjects must agree to practice contraception

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 24 hours prior to the initiation of the study and they must agree to ongoing pregnancy testing and to practice contraception


Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

- Pregnant or breast feeding females

- Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention

- Unstable angina or myocardial infarction within 6 months prior to enrollment, NYHA class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker

- Uncontrolled hypertension, uncontrolled pulmonary hypertension or uncontrolled diabetes within 14 days prior to enrollment

- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment

- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

- Use of any other experimental drug or therapy within 14 days of baseline

- Known history of allergy to Captisol®

- Known sero-positive for active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are sero-positive because of hepatitis B virus vaccine are eligible

- Breakpoint cluster region-Abelson positive (BCR-ABL +) patients will be excluded from the study
Resources
Schedule
Study duration and period
Variable
Recruitment period
From Oct. 24, 2014
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Sofia Milunovich
Research Topic
Conditions:
  • Contiguous Stage II Adult Lymphoblastic Lymphoma
  • Noncontiguous Stage II Adult Lymphoblastic Lymphoma
  • Stage I Adult Lymphoblastic Lymphoma
  • Stage III Adult Lymphoblastic Lymphoma
  • Stage IV Adult Lymphoblastic Lymphoma
  • Untreated Adult Acute Lymphoblastic Leukemia

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