NCT00052624

Brief Summary

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma. PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

May 15, 2018

Status Verified

April 1, 2004

First QC Date

January 24, 2003

Last Update Submit

May 14, 2018

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent childhood cerebral astrocytoma

Interventions

transferrin-CRM107BIOLOGICAL

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the following tumor characteristics: * Unifocal * Unilateral and supratentorial * Diameter no greater than 3.5 cm by contrast-enhanced MRI * No more than 1 satellite tumor * Recurrent or progressive disease * Progressive disease defined as at least 25% increase in tumor volume by serial MRI or CT scans and/or at least 15% increase in the largest cross-sectional area of tumor as defined by the area of contrast agent enhancement * Must have received prior conventional treatment comprising both of the following: * Surgery (biopsy or debulking) * Radiation therapy * No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness, or clinically significant papilledema PATIENT CHARACTERISTICS: Age * 5 to 18 Performance status * Karnofsky 60-100% OR * Lansky Play 50-100% Life expectancy * At least 3 months Hematopoietic * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL * AST and ALT no greater than 2.5 times the upper limit of normal (ULN) * PT or aPTT no greater than 1.5 times ULN Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 months after study * No acute viral, bacterial, or fungal infection requiring therapy * Topical treatment for oral candidiasis allowed * No other concurrent medical condition that would preclude anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy * No prior transferrin-CRM107 Chemotherapy * More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * More than 3 months since prior biodegradable polymer wafers * No concurrent chemotherapy Endocrine therapy * Must be on stable dose of steroids for 7 days prior to infusion Radiotherapy * See Disease Characteristics * More than 3 months since prior radiotherapy * More than 3 months since prior stereotactic radiosurgery * More than 6 weeks since prior craniospinal irradiation * No prior brachytherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * More than 1 month since prior surgery including tumor surgery or debulking * No other concurrent surgery Other * More than 30 days since prior investigational agents * No other concurrent investigational therapy * No other concurrent anti-cancer drugs

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

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Orange County

Orange, California, 92868-3874, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytoma

Interventions

Tf-CRM107

Condition Hierarchy (Ancestors)

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

Study Officials

  • Patrick Rossi, MD

    Xenova Biomedix

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

July 1, 2002

Last Updated

May 15, 2018

Record last verified: 2004-04

Locations

US(2)