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Meningeal NeoplasmsPhase 4NCT00029523

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

A Phase 4 study testing Intrathecal (injected into the spinal fluid) DepoCyt, Intrathecal methotrexate and Intrathecal cytarabine (also known as ara-C) in people with Meningeal Neoplasms, run by Pacira Pharmaceuticals, Inc at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningeal Neoplasms
What is being tested?
Intrathecal (injected into the spinal fluid) DepoCyt, Intrathecal methotrexate and Intrathecal cytarabine (also known as ara-C)
How many people
100 participants
Where
23 sitesin 2 countries
Study dates
Apr 2001to Nov 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States21 sites

  • Emory Clinic, Department of Neurosurgery

    Atlanta, Georgia, 30322

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Beth Israel Deaconess Medical Center Dept. of Neurology

    Boston, Massachusetts, 02215

  • Rush Cancer Institute

    Chicago, Illinois, 60612

  • Case Western Reserve University Hospital of Cleveland

    Cleveland, Ohio, 44106

  • University of Colorado Hospital, Anschutz Cancer Pavilion

    Denver, Colorado, 80010

  • JFK Neuroscience Institute

    Edison, New Jersey, 08820

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224

  • University of Southern California, Norris Cancer Center

    Los Angeles, California, 90033

  • Loyola University Medical Center, Dept. of Hematology/Oncology

    Maywood, Illinois, 60153

  • Park Nicollet Institute, Oncology Research Program

    Minneapolis, Minnesota, 55416

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • University of Utah, Hunsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center

    San Antonio, Texas, 78284

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Georgetown University Medical Center Hematology/Oncology

    Washington D.C., District of Columbia, 20007

  • Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada2 sites

  • Toronto Sunnybrook Regional Cancer Center

    Toronto, Ontario, M4N3M5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E0V9

Other trials in Canada

About this study

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

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.

Being tested
Intrathecal (injected into the spinal fluid) DepoCyt, Intrathecal methotrexate, Intrathecal cytarabine (also known as ara-C)
Keywords
neoplastic, meningitis, cerebrospinal fluid, CSF, meningeal, meninges, CNS, Leptomeningeal Neoplasms
Medical subject headings
Meningeal Neoplasms, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathecal (injected into the spinal fluid) DepoCytDrug

  • Intrathecal methotrexateDrug

  • Intrathecal cytarabine (also known as ara-C)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2002 (estimated)
  2. Study startApr 2001
  3. Study completionNov 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00029523
Sponsor's protocol ID
SKY0101-010
Status last verified
Feb 2007
First submitted
15 Jan 2002
Last updated
28 Feb 2007
Results posted
No

Publications

  • Glantz MJ, Jaeckle KA, Chamberlain MC, Phuphanich S, Recht L, Swinnen LJ, Maria B, LaFollette S, Schumann GB, Cole BF, Howell SB. A randomized controlled trial comparing intrathecal sustained-release cytarabine (DepoCyt) to intrathecal methotrexate in patients with neoplastic meningitis from solid tumors. Clin Cancer Res. 1999 Nov;5(11):3394-402.

    PubMed 10589750

  • Glantz MJ, LaFollette S, Jaeckle KA, Shapiro W, Swinnen L, Rozental JR, Phuphanich S, Rogers LR, Gutheil JC, Batchelor T, Lyter D, Chamberlain M, Maria BL, Schiffer C, Bashir R, Thomas D, Cowens W, Howell SB. Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. J Clin Oncol. 1999 Oct;17(10):3110-6. doi: 10.1200/JCO.1999.17.10.3110.

    PubMed 10506606

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intrathecal (injected into the spinal fluid) DepoCyt, Intrathecal methotrexate and Intrathecal cytarabine (also known as ara-C) in people with Meningeal Neoplasms, run by Pacira Pharmaceuticals, Inc at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival, defined as the time to neurological progression or death. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00029523, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2007.

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