Status:
TERMINATED
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Non-hodgkins Lymphoma
Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an exploratory study to study the efficacy of combination regimen of Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients with any form of lymphoid maligna...
Detailed Description
This phase II trial will study the effectiveness of a combination regimen which includes Oncaspar (PEG-asparaginase), Doxil (PEG-liposomal doxorubicin), and Decadron (ODD) in terms of disease response...
Eligibility Criteria
Inclusion
- Histologically documented lymphoid malignancies, regardless of their origin (B,T or NK). These include ALL, CLL, HL, NHL, MM and PCL.
- Patients must have failed at least one standard regimen of chemotherapy for their illness. They may have had unlimited prior regimens.
- Performance status of ≤ 2 as per ECOG scale.
- ALT \< 2.5 times the upper limit of normal
- Anticipated life expectancy of at least 12 weeks
- Patients will be allowed to have baseline cytopenias, but ANC should be \>200/μl and a platelet count \> 25,000/ μl (within 2 weeks of starting therapy).
- Patients must have a serum creatinine level ≤ 2 mg/dL (within 2 weeks of starting therapy).
- Male or female adults of at least 18 years of age.
- Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations
- Left Ventricular Ejection Fraction (LVEF) \> 40% by echocardiogram or MUGA scan performed within 60 days prior to registration
- Women and men of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy.
Exclusion
- Chemotherapy or radiotherapy received within the previous 2 weeks.
- Uncontrolled, active infection requiring IV antibiotics.
- Psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- Pregnant or potential for pregnancy.
- Breast-feeding.
- Prior asparaginase therapy complicated by pancreatitis, allergic reaction, hemorrhagic event, or thrombosis
- Previous treatment with pegylated asparaginase
- Prior doxorubicin exposure, more than 400 mg/m2
- Clinically significant CHF
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three year interval.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00837200
Start Date
March 1 2009
End Date
October 1 2013
Last Update
July 24 2017
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17070