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Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
transferrin-CRM107
Sponsored by
Xenova Biomedix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood cerebral astrocytoma

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Orange County
  • Hollings Cancer Center at Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2003
Last Updated
May 14, 2018
Sponsor
Xenova Biomedix
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1. Study Identification

Unique Protocol Identification Number
NCT00052624
Brief Title
Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
Official Title
A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Xenova Biomedix

4. Oversight

5. Study Description

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
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma. Determine the safety of this drug in these patients. Determine the efficacy of this drug in these patients. Compare the efficacy of this drug in patients with different histological types of tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody titer levels. OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups by age (5-9 vs 10-18). All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107). Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter. Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose (MTD) is determined. Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined. The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 6 months and then every 3 months for 6 months. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent childhood cerebral astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
transferrin-CRM107

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Rossi, MD
Organizational Affiliation
Xenova Biomedix
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868-3874
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma

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