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OpenTrials
Completed

NCT Number: NCT00029523

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

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.

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Key information

Conditions

Meningeal Neoplasms Central Nervous System Neoplasms Meningitis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neuroinflammatory Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CancerCare Manitoba, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Intrathecal (injected into the spinal fluid) DepoCyt

Drug

Intrathecal Methotrexate

Drug

Intrathecal cytarabine (also known as ara-C)

Drug

Primary outcomes

  1. Progression-free survival, defined as the time to neurological progression or death

Secondary outcomes

  1. Time to neurological progression;

  2. Survival (all-cause and meningeal disease-specific)

  3. Frequency of improvement in pre-existing meningeal-disease related neurological deficits

  4. Karnofsky Performance Scores (KPS)

  5. Quality of life

  6. Cytological response rate

  7. Overall safety profile

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study title

A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Important dates

Study start
2001
Study completion
2004
First posted
Jan 16, 2002
Registry last updated
Feb 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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