Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | March 2009 |
| End Date: | March 2011 |
The purpose of this study is to establish toxicity and a maximum tolerated dose recommended
phase 2 dose of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of
relapsed or refractory acute leukemias. The investigators will observe responses with these
therapy agents and assess the impact of Clofarabine interacting with Etoposide in induction
of DNA strand breaks.
phase 2 dose of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of
relapsed or refractory acute leukemias. The investigators will observe responses with these
therapy agents and assess the impact of Clofarabine interacting with Etoposide in induction
of DNA strand breaks.
This will be a phase I study with a standard 3x3 design. Patients will proceed to treatment
through a series of cohorts with the three drugs being delivered over five days beginning
with a dose of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8 mg/m2 days 1-3, and clofarabine
at 20 mg/m2 IV on days 2-6. Presuming this and subsequent cohorts are tolerable and no more
than 1 patient per cohort develops DLT, MTD patients will be treated in cohorts of 3-6
patients up to a final dose level of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8 mg/m2
days 1-5, and Clofarabine at 30 mg/m2 IV on days 2-6. Patients failing to enter remission may
receive 4 days of therapy with Etoposide 100 mg/m2 on days 1-4,Mitoxantrone 8 mg/m2 days 1-2
or 1-4,and Clofarabine at 20-30 mg/m2 IV on days 1-4. According to established definitions
for dose limiting toxicity a recommended phase II dose will be established. After this is
established the final cohort will be expanded to 15 patients.
through a series of cohorts with the three drugs being delivered over five days beginning
with a dose of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8 mg/m2 days 1-3, and clofarabine
at 20 mg/m2 IV on days 2-6. Presuming this and subsequent cohorts are tolerable and no more
than 1 patient per cohort develops DLT, MTD patients will be treated in cohorts of 3-6
patients up to a final dose level of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8 mg/m2
days 1-5, and Clofarabine at 30 mg/m2 IV on days 2-6. Patients failing to enter remission may
receive 4 days of therapy with Etoposide 100 mg/m2 on days 1-4,Mitoxantrone 8 mg/m2 days 1-2
or 1-4,and Clofarabine at 20-30 mg/m2 IV on days 1-4. According to established definitions
for dose limiting toxicity a recommended phase II dose will be established. After this is
established the final cohort will be expanded to 15 patients.
Inclusion Criteria:
- Adequate renal and hepatic function.
- Capable of understanding the investigational nature, potential risks and benefits of
the study and able to provide valid informed consent.
- Female patients of childbearing potential must have a negative serum pregnancy test
within 2 weeks prior to enrollment.
- Male and female patients must use an effective contraceptive method during the study
and for a minimum of 6 months after study treatment.
- LVEF must be ≥ 50% within 2 weeks.
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
specified in the protocol.
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
before study entry with the exception of hydroxyurea. The patient must have recovered
from all acute toxicities from any previous therapy.
- Have any other severe concurrent disease, or have a history of serious organ
dysfunction or disease involving the heart, kidney, liver or other organ system that
may place the patient at undue risk to undergo treatment.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled.
- Any significant concurrent disease, illness, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow-up or interpretation of study results.
- Have had a diagnosis of another malignancy, unless the patient has been disease free
for at least 3 years following the completion of curative intent therapy with the
following exceptions: patients with treated non-melanoma skin cancer, in situ
carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free
duration, are eligible for the study if definitive treatment for the condition has
been completed. Patients with organ-confined prostate cancer with no evidence of
recurrent or progressive disease based on prostate-specific antigen values are also
eligible for this study if hormonal therapy has been initiated or a radical
prostatectomy has been performed. Additionally, patients with prostate cancer treated
with radiation therapy are also eligible for the study.
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