Status:
TERMINATED
A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment (chemotherapy) drug cal...
Detailed Description
The purpose of this research study is for the study's sponsor, Enzon Pharmaceuticals, Inc. ("Enzon"), to learn more about its drug pegaspargase. Pegaspargase is the drug's scientific or generic name. ...
Eligibility Criteria
Inclusion
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's), and have either failed primary treatment or there is no available standard treatment.
- Prior standard therapy was not effective, or no known therapy will extend survival or provide benefit.
- Measurable or evaluable disease.
- Age 18 years or older.
- Score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- Absolute neutrophil count (ANC)≥ 1500/μL.
- Platelet count ≥ 100,000/μL.
- Hemoglobin ≥ 9.0 g/dL.
- Fibrinogen ≥ 0.75x the lower limit of normal (LLN), and PT, PTT, and INR ≤ 1.5x the upper limit of normal (ULN).
- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
- Total bilirubin ≤ 1.5 mg/dL.
- Transaminases (AST, ALT) ≤ 2.5x the upper limit of normal (ULN) (may be ≤ 5.0x ULN if due to metastatic disease in the liver).
- Amylase and lipase levels are within normal limits.
- Any subject who has given informed consent to participate in the clinical study and who meets all entry criteria for the study may participate in the tumor analysis part of the study.
Exclusion
- Subjects meeting any of the following exclusion criteria will not be eligible for enrollment.
- Concurrent serious medical illness that could potentially interfere with protocol compliance.
- Has pancreatitis or a history of pancreatitis, not related to pancreatic cancer.
- Has a coagulopathy or a history of coagulopathy.
- Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
- Positive screening pregnancy test or is breast-feeding.
- Female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
- Known or clinically suspected active brain metastases.
- Received pegaspargase (Oncaspar®, PEG-L-asparaginase) or any asparaginase or asparaginase-containing drug, at any time prior to this study.
- Received prior chemotherapy, immunotherapy or an investigational agent regimen
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00363610
Start Date
July 1 2006
End Date
June 1 2008
Last Update
May 20 2008
Active Locations (3)
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1
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-8511
3
Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229