NCT00036972

Brief Summary

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma. PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy before and after surgery in treating patients who have recurrent malignant glioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2001

Longer than P75 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

November 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 26, 2013

Status Verified

December 1, 2009

Enrollment Period

3.2 years

First QC Date

May 13, 2002

Last Update Submit

June 25, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

cintredekin besudotoxBIOLOGICAL
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial malignant glioma (grade 3 or 4) * Anaplastic astrocytoma * Glioblastoma multiforme * Mixed oligoastrocytoma * Malignant astrocytoma, not otherwise specified * Prior first resection of brain tumor * Prior cranial radiotherapy with tumor dose of at least 48 Gy * Radiographic evidence of recurrent or progressive supratentorial tumor * In patients who have received external beam radiotherapy or localized radiotherapy (e.g., gamma-knife or brachytherapy) within the past 12 weeks, progression must be confirmed by metabolic imaging (magnetic resonance spectroscopy or positron-emission tomography) * Must be a candidate for second resection * No signs of impending herniation * No midline shift greater than 1 cm * No multifocal disease or subependymal tumor spread PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * PT and PTT no greater than upper limit of normal Renal: * Not specified Other: * No uncontrolled seizures * No other neurologic condition that would interfere with study evaluation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 60 days after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior cytotoxic therapy (2 weeks for vincristine or 6 weeks for nitrosoureas) Endocrine therapy: * Concurrent steroids allowed * No tapering of steroids during or immediately after study infusion Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * At least 4 weeks since prior investigational agents * At least 2 weeks since prior non-cytotoxic agents * No other concurrent antitumor therapy

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

Related Publications (1)

  • Kunwar S, Prados MD, Chang SM, Berger MS, Lang FF, Piepmeier JM, Sampson JH, Ram Z, Gutin PH, Gibbons RD, Aldape KD, Croteau DJ, Sherman JW, Puri RK; Cintredekin Besudotox Intraparenchymal Study Group. Direct intracerebral delivery of cintredekin besudotox (IL13-PE38QQR) in recurrent malignant glioma: a report by the Cintredekin Besudotox Intraparenchymal Study Group. J Clin Oncol. 2007 Mar 1;25(7):837-44. doi: 10.1200/JCO.2006.08.1117.

    PMID: 17327604BACKGROUND

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliomaGliosarcoma

Interventions

IL13-PE38Chemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Lauren E. Abrey, 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

May 13, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

January 1, 2005

Study Completion

December 1, 2009

Last Updated

June 26, 2013

Record last verified: 2009-12

Locations

US(1)