NCT00523939

Brief Summary

The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 14, 2011

Completed
Last Updated

June 17, 2013

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

August 31, 2007

Results QC Date

February 16, 2011

Last Update Submit

June 7, 2013

Conditions

Neoplastic MeningitisLymphoma, B Cell

Keywords

LymphomaLeukemiaLeukemic MeningitisLymphomatous Meningitis

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.

    1 year

Secondary Outcomes (1)

  • Time to Neurologic Progression

    2 years

Study Arms (2)

Lymphomatous

EXPERIMENTAL

Subjects with Lymphomatous Meningitis

Drug: cytarabine liposome injection

Leukemic

EXPERIMENTAL

Subjects with Leukemic Meningitis

Drug: cytarabine liposome injection

Interventions

cytarabine liposome injectionDRUG

50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Also known as: DepoCyt
LeukemicLymphomatous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cytologically confirmed, or radiographic evidence for lymphomatous or leukemic meningitis. If the CSF cytology is negative, patients must have MRI/CT brain and clinical findings consistent with neoplastic meningitis.
  • Karnofsky Performance Score of 60 or above.
  • Age ≥ 18 years.
  • Patients must have adequate hematologic, renal and liver function. Laboratory
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3 or white blood cell count \> 3,000/mm3
  • Platelet count ≥ 100, 000/mm3
  • BUN and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal
  • Total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal
  • SGOT and SGPT ≤ 3.0 times upper limit of laboratory normal
  • Alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal
  • No uncontrolled infection other than human immunodeficiency virus that is being treated with anti-retroviral therapy
  • Patients who have had prior CNS radiation, prior intrathecal methotrexate, and prior CNS prophylaxis with intrathecal or intravenous cytarabine or methotrexate are eligible
  • Written informed consent

You may not qualify if:

  • Experimental/Investigational chemotherapy, immunotherapy, or biologic therapy within four weeks prior to study
  • Concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine, or high dose thiotepa (they cross the blood brain barrier at high levels)
  • Patients receiving whole brain radiotherapy or craniospinal irradiation
  • Previous (less than 2 years from diagnosis) or concurrent malignancies at other sites with the exception of fully treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer not requiring ongoing chemotherapy
  • Pregnant or lactating women
  • Known active meningeal infection
  • Evidence of obstructive hydrocephalus requiring neurosurgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Meningeal CarcinomatosisLymphoma, B-CellLymphomaLeukemia

Condition Hierarchy (Ancestors)

Meningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesLymphoma, Non-HodgkinNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Limitations and Caveats

Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.

Results Point of Contact

Title
Dr. David Rizzieri
Organization
Duke University Medical Center
rizzi003@mc.duke.edu
919-668-1040

Study Officials

  • David Rizzieri, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

June 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 17, 2013

Results First Posted

March 14, 2011

Record last verified: 2012-11

Locations

US(1)