Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies
Condition: Non-hodgkins Lymphoma; Hodgkins Lymphoma; Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma
Intervention: Oncaspar, Doxil, Decadron
Intervention description: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Asparaginase; Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lymphoma; myeloma

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.
    

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.