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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052624
First received: January 24, 2003
Last updated: February 6, 2009
Last verified: April 2004
  Purpose

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


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: transferrin-CRM107
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2002
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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052624

Locations
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868-3874
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Xenova Biomedix
Investigators
Study Chair: Patrick Rossi, MD Xenova Biomedix
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00052624     History of Changes
Other Study ID Numbers: CDR0000258574, KSB-311P/CI/001, MUSC-10550
Study First Received: January 24, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood cerebral astrocytoma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014