Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors, Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

EZ-002-001

NCT ID:

NCT00363610

Start Date:

July 2006

Completion Date:

June 2008

Related Keywords:

  • Tumors
  • Lymphoma
  • Advanced and/or Metastatic Solid Tumors and Lymphoma
  • Lymphoma

Name

Location

University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258
Cancer Therapy & Research Center, Institute for Drug DevelopmentSan Antonio, Texas  78229