Non Hodgkin Lymphoma Clinical Trial

Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

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 malignancy will be eligible: acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and plasma cell leukemia. Patients must have failed standard regimens for their cancers and could have had unlimited number of prior regimens. Patients will be staged appropriately for their disease with clinical examination, laboratory tests, and imaging studies. Both Oncaspar and Doxil will be given on day 1 and 15. Patients will be clinically evaluated prior to each cycle and will have disease assessments every 2 cycles. Responding patients will continue therapy until disease progression or excessive toxicity. Responders who are candidates for allogenic stem cell transplantation could go to conditioning chemotherapy and stem cell transplant after 4 cycles of ODD.

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Full 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 against refractory lymphoid malignancies. Asparaginase is an enzyme that depletes asparagines, a key amino acid for survival and growth of malignant lymphocytes. Its depletion results in death of the neoplastic cell. Asparagine depletion has induced a significant improvement of clinical outcomes in acute lymphoblastic leukemia (ALL) and L-asparaginase has been a mainstay for more than 30 years in the treatment of ALL. Although this drug has been used primarily in ALL, promising results have been reported even in other non-ALL lymphoid malignancies, such as chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, refractory non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). One of the main goals of this trial is to measure the asparaginase level as a surrogate marker of asparagine depletion with Oncaspar, a PEG-enhanced version of E. coli L-asparaginase. The therapeutic value of the simple, non-pegylated form of L-asparaginase is limited by its short half-life and propensity to cause allergic reactions.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT00837200

Recruitment Status:

Terminated

Sponsor:

Milton S. Hershey Medical Center

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There is 1 Location for this study

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Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17070, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT00837200

Recruitment Status:

Terminated

Sponsor:


Milton S. Hershey Medical Center

How clear is this clinincal trial information?

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