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Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

Primary Purpose

Non-hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oncaspar, Doxil, Decadron
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-hodgkins Lymphoma focused on measuring lymphoma, myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oncaspar, Doxil, Decadron Regimen

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Study Specific Measure (Response)
Study Specific Measure (Number of Participants Taken Off Study)

Secondary Outcome Measures

Full Information

First Posted
February 4, 2009
Last Updated
June 23, 2017
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00837200
Brief Title
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies
Official Title
Phase II Pilot Efficacy Trial of the Combination Regimen Oncaspar/Doxil/Decadron (ODD) in Patients With Refractory Lymphoid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
PI said to close accrual do to funding
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma
Keywords
lymphoma, myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oncaspar, Doxil, Decadron Regimen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oncaspar, Doxil, Decadron
Other Intervention Name(s)
PEG-asparaginase, PEG-liposomal doxorubicin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor Response
Description
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
Time Frame
16 weeks
Title
Study Specific Measure (Response)
Time Frame
16 Weeks
Title
Study Specific Measure (Number of Participants Taken Off Study)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J. Drabick, MD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17070
Country
United States

12. IPD Sharing Statement

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Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

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