- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837200
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies
June 23, 2017 updated by: Joseph Drabick, Milton S. Hershey Medical Center
Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies
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.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17070
- Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oncaspar, Doxil, Decadron Regimen
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response
Time Frame: 16 weeks
|
|
16 weeks
|
Study Specific Measure (Response)
Time Frame: 16 Weeks
|
16 Weeks
|
|
Study Specific Measure (Number of Participants Taken Off Study)
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph J. Drabick, MD, Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Actual)
July 24, 2017
Last Update Submitted That Met QC Criteria
June 23, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Multiple Myeloma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
- Asparaginase
- Pegaspargase
Other Study ID Numbers
- 08-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Oncaspar, Doxil, Decadron
-
OncotherapeuticsCelgene CorporationCompletedMultiple MyelomaUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); ShireActive, not recruitingAcute Lymphoblastic Leukemia | Lymphoblastic LymphomaUnited States, Canada, Puerto Rico
-
Hematology and Oncology SpecialistsUnknownAutoimmune Thrombocytopenic PurpuraUnited States
-
medac GmbHTerminatedAcute Lymphoblastic LeukaemiaGermany
-
Janssen Research & Development, LLCCompletedNeoplasmsUnited States, Spain, Canada, Belgium
-
National Center for Research Resources (NCRR)Unknown
-
Assistance Publique - Hôpitaux de ParisShireRecruitingAcute Lymphoblastic LeukemiaFrance
-
National Cancer Institute (NCI)CompletedOvarian Neoplasms | Fallopian Tube Neoplasms | Primary Peritoneal NeoplasmsUnited States
-
Sham Sunder KakarUniversity of Louisville Health CareRecruiting
-
West Virginia UniversityOrtho Biotech, Inc.CompletedMetastatic Breast CancerUnited States