Non-hodgkins LymphomaPhase 2NCT00837200
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies
A Phase 2 study testing Oncaspar, Doxil, Decadron in people with Non-hodgkins Lymphoma and Hodgkins Lymphoma, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma
- What is being tested?
- Oncaspar, Doxil, Decadron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17070
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma
- Being tested
- Oncaspar, Doxil, Decadron
- Keywords
- lymphoma, myeloma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncaspar, Doxil, DecadronDrug
Also called PEG-asparaginase, PEG-liposomal doxorubicin
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.
| Study group | Role | What they receive |
|---|---|---|
| Oncaspar, Doxil, Decadron Regimen | Experimental | 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. Receives: Drug: Oncaspar, Doxil, Decadron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
- Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU
- Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles
- MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion
- Stable disease > 2mo was a response
Measured: 16 weeks
Study Specific Measure (Response)
Measured: 16 Weeks
Study Specific Measure (Number of Participants Taken Off Study)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionOct 2013
Why it stopped: PI said to close accrual do to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-hodgkins LymphomaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Drabick, Milton S. Hershey Medical Center
- Investigators
- Joseph J. Drabick, MD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837200
- Sponsor's protocol ID
- 08-007
- Status last verified
- Jun 2017
- First submitted
- 4 Feb 2009
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00837200
- Acronym / sponsor ID
- 08-007
- Conditions
- Non-hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma
- Keywords
- lymphoma, myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI said to close accrual do to funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncaspar, Doxil, Decadron Regimen | Experimental | Drug: Oncaspar, Doxil, DecadronOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncaspar, Doxil, DecadronAlso: PEG-asparaginase, PEG-liposomal doxorubicinOnce 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. | Drug | Oncaspar, Doxil, Decadron Regimen |
Primary outcome
Tumor Response
Time frame: 16 weeks
* Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU * Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles * MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion * Stable disease > 2mo was a response
Study Specific Measure (Response)
Time frame: 16 Weeks
Study Specific Measure (Number of Participants Taken Off Study)
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J. Drabick, MD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncaspar, Doxil, Decadron in people with Non-hodgkins Lymphoma and Hodgkins Lymphoma, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.