Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma - Full Text View

Sponsor:	Xenova Biomedix
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052624

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

recurrent childhood cerebral astrocytoma

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009