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A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood (NCT00003909)

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma
  • Drug: motexafin gadolinium
    Given IV
    • gadolinium texaphyrin
    • Gd (III) Texaphryin
    • Gd-Tex
    • PCI-0120
    • Xcytrin
  • Radiation: radiation therapy
    Undergo radiation therapy
    • irradiation
    • radiotherapy
    • therapy, radiation
  • Other: pharmacological study
    Correlatives studies
    • pharmacological studies
Ages eligible for Study
up to 21 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma.

II. Determine the toxic effects of this drug given at the MTD in these patients.

III. Determine the intratumor and brain distribution of this drug by magnetic resonance imaging (MRI) in these patients.

OUTLINE: This is a dose-escalation study of motexafin gadolinium.

Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.

1 locations

United States (1)
  • Children's Oncology Group
    Arcadia, California, United States, 91006-3776
Status:
completed
Type:
Interventional
Phase:
Start:
31 July, 1999
Updated:
14 January, 2013
Participants:
24
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