Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies
18 Years
N/A
Both
Non-hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma
Trial Information
Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
tumor response
Outcome Time Frame:
16 weeks
Safety Issue:
Yes
Principal Investigator
Joseph J. Drabick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Penn State University
Authority:
United States: Institutional Review Board
Study ID:
08-007
NCT ID:
NCT00837200
Start Date:
March 2009
Completion Date:
November 2013
Related Keywords:
- Non-Hodgkins Lymphoma
- Hodgkins Lymphoma
- Multiple Myeloma
- lymphoma
- myeloma
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
