DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

This study has been completed.
Information provided by:
Pacira Pharmaceuticals, Inc Identifier:
First received: January 15, 2002
Last updated: February 27, 2007
Last verified: February 2007
The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.

Condition Intervention Phase
Meningeal Neoplasms
Drug: Intrathecal (injected into the spinal fluid) DepoCyt
Drug: Intrathecal methotrexate
Drug: Intrathecal cytarabine (also known as ara-C)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Resource links provided by NLM:

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Progression-free survival, defined as the time to neurological progression or death

Secondary Outcome Measures:
  • Time to neurological progression;
  • Survival (all-cause and meningeal disease-specific)
  • Frequency of improvement in pre-existing meningeal-disease related neurological deficits
  • Karnofsky Performance Scores (KPS)
  • Quality of life
  • Cytological response rate
  • Overall safety profile

Estimated Enrollment: 100
Study Start Date: April 2001
Estimated Study Completion Date: November 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia)
  • Diagnosed with neoplastic meningitis
  • If female, not pregnant and will not become pregnant while on-study
  • No other experimental therapy within 21 days of participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00029523

  Show 23 Study Locations
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Study Director: Ahmet Tutuncu, MD, PhD Pacira Pharmaceuticals, Inc
  More Information

Publications: Identifier: NCT00029523     History of Changes
Other Study ID Numbers: SKY0101-010 
Study First Received: January 15, 2002
Last Updated: February 27, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
cerebrospinal fluid
Leptomeningeal Neoplasms

Additional relevant MeSH terms:
Meningeal Carcinomatosis
Meningeal Neoplasms
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 03, 2016