Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Asparaginase; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Pegaspargase

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.