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Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-hodgkins Lymphoma; Hodgkins Lymphoma; Multiple Myeloma

Intervention: Oncaspar, Doxil, Decadron (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Joseph J. Drabick, MD, Principal Investigator, Affiliation: Penn State University


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.

Clinical Details

Official title: Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Tumor Response

Study Specific Measure (Response)

Study Specific Measure (Number of Participants Taken Off Study)

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 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

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

Starting date: March 2009
Last updated: September 18, 2014

Page last updated: August 23, 2015

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