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

Study 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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 5 Years - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00052624
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Xenova Biomedix
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Patrick Rossi, MD
Principal Investigator Affiliation Xenova Biomedix
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Unknown status
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Orange County, Orange, California

Status

Address

Children's Hospital of Orange County

Orange, California, 92868-3874

Charleston, South Carolina

Status

Address

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425

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