A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enzon Pharmaceuticals, Inc.
• Treatments: Gemcitabine; Pegaspargase

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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