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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Intratumoral Transferrin-CRM107 in Pediatric Patients With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	5 to 18	Other, Pharmaceutical / Industry	KSB-311P/CI/001 MUSC-10550, NCT00052624

Trial Description

Purpose:

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.

Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma

Eligibility:

• 5-18 years old
• Must have undergone surgery and radiation therapy
• No previous immunotoxin
• More than 1 month since chemotherapy or surgery
• More than 3 months since radiation therapy
• More than 6 weeks since radiation therapy to the head and spine
• No previous brachytherapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will undergo a biopsy and placement of catheters into the tumor on day 1. They will then receive a 3- to 7-day continuous infusion of the immunotoxin directly into the tumor. Treatment may be repeated in 6-10 weeks. Patients will be evaluated once a month for 6 months and then every 3 months for 6 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Xenova Biomedix Limited

Patrick Rossi, MD, Protocol chair		Ph: 856-273-6057

Registry Information
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
Trial Start Date		2002-07-26
Registered in ClinicalTrials.gov		NCT00052624
Date Submitted to PDQ		2002-10-25
Information Last Verified		2004-04-27

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