Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the safety, serious adverse effects and how the body handles CPX-351. Preliminary evidence of antitumor activity will also be determined.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celator Pharmaceuticals; Jazz Pharmaceuticals
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• Ability to understand and voluntarily sign an informed consent form

• Age > 18 years at the time of signing the informed consent form

• Pathological confirmation of leukemia or myelodysplastic syndrome.

• AML according to WHO criteria; except for core-binding factor AMLs (t(8;21), inv(16) or t(16;16)) and APL

• ALL

• MDS

• Patients with AML include the following:

• Patients in 2nd or greater relapse

• Patients in first relapse with initial CR duration lasting <6 months

• Patients in first relapse refractory to induction therapy

• Patients with primary refractory AML

• Patients with ALL include the following

• Patients with T-cell ALL refractory or in relapse following nelarabine

• Patients with other ALL that is refractory or in relapse.

• Patients with MDS include the following:

• The subset of RAEB-2 patients with >10% blasts with at least 1 prior therapy that includes a hypomethylating agent.

• Previously untreated chemotherapy induced AML

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2

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

• Life expectancy of at least 12 weeks

• Laboratory values fulfilling the following:

• Serum creatinine < 1.5 mg/dL

• Serum total bilirubin < 1.5 mg/dL

• Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.

• Cardiac ejection fraction > 50% by MUGA scan or echocardiography

• All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.

Exclusion Criteria:

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

• Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry

• Clinical evidence of active CNS leukemic involvement

• Pregnant or lactating women

• Clinically significant cardiac disease (New York Heart Association Class III or IV)

• Severe debilitating pulmonary disease

• Active and uncontrolled infection. Patients with an infection under active treatment with antibiotics and whose infection is controlled may be entered into the study

• Current evidence of invasive fungal infection (blood or tissue culture); HIV or hepatitis C infection

• Hypersensitivity to cytarabine, daunorubicin or liposomal products

• History of Wilson's disease or other copper-related disorder