Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 2029 for:    doxil

Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00837200
Recruitment Status : Terminated (PI said to close accrual do to funding)
First Posted : February 5, 2009
Results First Posted : August 20, 2014
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Drabick, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-hodgkins Lymphoma
Hodgkins Lymphoma
Multiple Myeloma
Intervention Drug: Oncaspar, Doxil, Decadron
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ODD Regimen
Hide Arm/Group 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.

Oncaspar, Doxil, Decadron: 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.

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  46.2%
>=65 years
7
  53.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
64.9
(46 to 80)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Participants over 70 years old 6
Partipants under 70 years old 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
9
  69.2%
Male
4
  30.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
Participants Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Multiple Myeloma 7
Diffuse Large B-cell Lymphoma 6
Prior Regimens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Pre-Treated with 3 Median prior Regimens 3
Not treated with Prior Regimens 10
1.Primary Outcome
Title Tumor Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ODD Regimen
Hide Arm/Group 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.

Oncaspar, Doxil, Decadron: 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.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
2
2.Primary Outcome
Title Study Specific Measure (Response)
Hide Description [Not Specified]
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ODD Regimen
Hide Arm/Group 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.

Oncaspar, Doxil, Decadron: 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.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Not Evaluable for Response 1
Stable Disease > 2 months 2
Progressive Disease 10
3.Primary Outcome
Title Study Specific Measure (Number of Participants Taken Off Study)
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ODD Regimen
Hide Arm/Group 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.

Oncaspar, Doxil, Decadron: 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.

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Due to Oncaspar-Related Toxicities 1
Not De to Oncaspar-Related Toxicities 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ODD Regimen
Hide Arm/Group 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.

Oncaspar, Doxil, Decadron: 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.

All-Cause Mortality
ODD Regimen
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ODD Regimen
Affected / at Risk (%) # Events
Total   9/13 (69.23%)    
Gastrointestinal disorders   
Mucositis  1  1/13 (7.69%) 
Emesis  1  1/13 (7.69%) 
Nausea  1  1/13 (7.69%) 
Dehydration  1  2/13 (15.38%)  2
Anorexia  1  1/13 (7.69%) 
Infections and infestations   
Sepsis  1  1/13 (7.69%) 
Infection - unk ANC  1  1/13 (7.69%) 
Fever  1  1/13 (7.69%) 
Metabolism and nutrition disorders   
Elevated Alk Phos  1  1/13 (7.69%) 
Elevated AST  1  1/13 (7.69%) 
Renal and urinary disorders   
Acute Renal Failure  1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/13 (7.69%)  1
Dyspnea  1  1/13 (7.69%) 
Vascular disorders   
Pulmonary Emboli  1  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ODD Regimen
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Decreased WBC  1  7/13 (53.85%) 
Decreased ANC  1  4/13 (30.77%) 
Decreased Platelets  1  6/13 (46.15%) 
Decreased Hemoglobin  1  8/13 (61.54%) 
Metabolism and nutrition disorders   
Elevated AST  1  3/13 (23.08%) 
Elevated ALT  1  3/13 (23.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph J Drabick, MD
Organization: Milton S Hershey Medical Center
Phone: 717-531-5911
EMail: jdrabick@hmc.psu.edu
Layout table for additonal information
Responsible Party: Joseph Drabick, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00837200     History of Changes
Other Study ID Numbers: 08-007
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: May 2, 2014
Results First Posted: August 20, 2014
Last Update Posted: July 24, 2017