NCT00022360

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent or progressive glioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2001

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

March 19, 2004

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

August 10, 2001

Last Update Submit

June 17, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

taurolidineDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma Recurrent or progressive disease after prior cytoreductive surgery, radiotherapy, and adjuvant chemotherapy Ineligible for any additional conventional therapeutic intervention PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 3 times upper limit of normal No indication of acute hepatitis or parenchymal liver disease No significant hepatic disease that would preclude study Renal: Creatinine less than 1.7 mg/dL No significant renal disease that would preclude study Cardiovascular: No significant cardiac disease that would preclude study Other: HIV negative No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No significant psychiatric disease that would preclude study No significant gastrointestinal disease that would preclude study No known hypersensitivity to taurolidine or its excipients Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon Chemotherapy: See Disease Characteristics At least 2 weeks since prior vincristine At least 3 weeks since prior temozolomide or procarbazine At least 4 weeks since prior nitrosoureas Concurrent polifeprosan 20 with carmustine implant (Gliadel wafers) allowed Endocrine therapy: At least 2 weeks since prior tamoxifen Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 2 weeks since prior stereotactic radiosurgery Surgery: See Disease Characteristics Other: Recovered from prior therapy At least 30 days since prior investigational drug At least 2 weeks since other prior noncytotoxic agents No other concurrent experimental agent or protocol

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

taurolidine

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jeffrey J. Raizer, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

March 19, 2004

Study Start

May 1, 2001

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)