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A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

OBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic
oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and
quantitative toxicity of topotecan in this patient population on this schedule.

OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes
daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or
unacceptable toxicity. Patients will be followed every 3 months until death.

PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent anaplastic oligodendroglioma or
anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy Tumors
for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements
Tumors must be clinically aggressive for patients with only 1 anaplastic feature Prior low
grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical
or radiological progression are eligible Bidimensionally measurable and progressive
lesions by CT or MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine normal Other: Not pregnant
or nursing Fertile patients must use effective contraception No prior malignancies except
curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other
serious illness or medical condition No active uncontrolled infection No history of
neurologic or psychiatric disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since chemotherapy No more than 1 prior chemotherapy regimen No prior camptothecin
derivatives Endocrine therapy: At least 2 weeks on stable steroid therapy, if necessary
Radiotherapy: At least 2 months since prior radiotherapy No prior radiation therapy for
recurrent disease Surgery: At least 6 weeks since prior surgery (except biopsy only) Prior
surgery for recurrent disease allowed (including stereotactic biopsy or partial resection)
Other: No concurrent experimental drugs or anticancer therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Karl Belanger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CHUM - Hotel Dieu Hospital


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

December 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Oligodendroglioma
  • Central Nervous System Neoplasms
  • Astrocytoma