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Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: Etoposide, Mitoxantrone, Clofarabine (Drug); Clofarabine, Etoposide, Mitoxantrone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
David F. Claxton, MD, Principal Investigator, Affiliation: Penn State College of Medicine

Summary

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.

Clinical Details

Official title: Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Establish toxicity of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of relapsed or refractory acute leukemias

Establish dose limiting toxicity of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of relapsed or refractory acute leukemias

Establish maximum tolerated dose recommend Phase 2 dose of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of relapsed or refractory acute leukemias

Secondary outcome:

Observe response of relapsed or refractory acute leukemias to therapy with these agents.

Assess the impact of Clofarabine interacting with Etoposide and Mitoxantrone in induction of DNA strand breaks

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Penn State Hershey Cancer Institute, Hershey, Pennsylvania 17033, United States
Additional Information

Starting date: March 2009
Last updated: December 4, 2014

Page last updated: August 23, 2015

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