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Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasm

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Trial Information

Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas


Inclusion Criteria:



- At least 18 years old

- Histologically confirmed diagnosis of malignant gliomas that requires systemic
antineoplastic treatment. Malignant glioma is defined as any of the following:
Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic
oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except
low-grade glioma)

- ECOG performance status score of 0, 1, or 2

- Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

- Absolute neutrophil count < 2000/µL

- Platelet count < 100,000/µL

- AST or ALT > 2 x the upper limit of normal (ULN)

- Alkaline phosphatase > 5 x ULN

- Bilirubin > 2 x ULN

- Creatinine > 2.0 mg/µL

and

- Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during
the study period

- Women who are pregnant or lactating

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0218

NCT ID:

NCT00080054

Start Date:

Completion Date:

Related Keywords:

  • Glioma
  • Glioblastoma
  • Astrocytoma
  • Oligodendroglioma
  • Brain Neoplasm
  • Malignant Glioma
  • Glioblastoma multiforme
  • GBM
  • Anaplastic astrocytoma
  • AA
  • Anaplastic oligodendroglioma
  • Anaplastic mixed glioma
  • Brain tumor
  • Brain neoplasm
  • Glioma
  • Astrocytoma
  • Brain Neoplasms
  • Neoplasms
  • Glioblastoma
  • Glioma
  • Oligodendroglioma

Name

Location

Barrow Neurological InstitutePhoenix, Arizona  85013