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

Condition(s) targeted: Tumors; Lymphoma

Intervention: Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Enzon Pharmaceuticals, Inc.

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®.

Official title: A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of Intravenous Pegaspargase in Combination With Intravenous Gemcitabine HCl in the Treatment of Advanced and/or Metastatic Solid Tumors and Lymphoma

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Primary outcome:

The primary objectives of this Phase 1 study of pegaspargase in combination with gemcitabine are to determine the maximum tolerated dose of IV pegaspargase when administered with gemcitabine

and to determine the recommended Phase 2 dose of pegaspargase

Secondary outcome:

The secondary objectives of this study are to evaluate the safety and tolerability of the combination study treatment

to determine the PD/PK profile and immunogenicity of pegaspargase

to determine the PK profile of gemcitabine when administered in combination with pegaspargase

and to detect preliminary evidence of tumor

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. Because it is already approved by the Food and Drug Administration (FDA),

it also has a brand name - ONCASPAR®. It is approved by the FDA for the treatment of a type

of leukemia (cancer of white blood cells). However, pegaspargase is not approved by the FDA for treatment of the cancer in this study. This study will research the side effects of pegaspargase when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl; its brand name is GEMZAR®. It is approved for the treatment of patients with cancer of the pancreas and of patients with breast cancer. However, gemcitabine is not approved by the FDA for treatment of any other types of cancer.

In addition, the combination of pegaspargase and gemcitabine for solid tumors and lymphoma in this study is investigational. This type of study treatment is called a "combination treatment" or a "combination study." The information (research data) from this study will be used by Enzon to plan other "combination" research studies with pegaspargase plus gemcitabine for the treatment of certain cancers.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

TGen Clinical Research Services at Scottsdale Healthcare, Scottsdale, Arizona 85258, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-8511, United States

Cancer Therapy & Research Center, Institute for Drug Development, San Antonio, Texas 78229, United States

Starting date: July 2006
Ending date: June 2008
Last updated: May 16, 2008