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Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

Phase 1
18 Years
Open (Enrolling)
Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma

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Trial Information

Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or
greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially
diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I
design used to determine maximum tolerated dose of topotecan in combination with Temodar.

Inclusion Criteria:

- Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed
glial tumors which were initially diagnosed by histologic exam of biopsy/resection

- Age: > or equal to 18 years

- Performance Status: Karnofsky Performance Status > or equal to 60% at study entry.

- Renal Function: Serum creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/dL.

- Hematologic Status: The following baseline studies will be required before entry:
total granulocyte count > or equal to 1000/microliter; platelet count >

- Hepatic Function: Serum SGOT & total bilirubin < or equal to 2.5 times ULN.

- Note: All lab parameters must have been obtained within 1 week of registration

- Consent: Signed informed consent, approved by IRB, will be obtained prior to
initiating treatment

- Corticosteroids: For patients currently on corticosteroids, patients should be on
stable dose for 1 week prior to study entry, if clinically possible.

- Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior
radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are <
or equal to grade 1 & enrollment on this protocol unless there is unequivocal
evidence of progressive disease.

- Patients with Reproductive Potential: Patients must agree to practice effective birth
control measures while on study and for 2 months after completing therapy

Exclusion Criteria:

- Pregnant or breast feeding women or women or men with reproductive potential not
practicing adequate contraception. This therapy may be associated with potential
toxicity to the fetus or child that exceeds minimum risks necessary to meet health
needs of mother

- Active infection requiring intravenous antibiotics

- Prior failure with either topotecan or temozolomide

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Katherine B Peters, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

March 2013

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • Anaplastic Astrocytoma
  • Temodar
  • Temozolomide
  • Topotecan
  • Hycamtin
  • Malignant Gliomas
  • Brain tumor
  • Anaplastic astrocytoma
  • AA
  • GBM
  • Glioblastoma Multiform
  • Gliosarcoma
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Gliosarcoma



Duke University Health System Durham, North Carolina  27705