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Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

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

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Trial Information

Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial
tumors to temozolomide treatment in patients with progressive disease during or after
procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and
toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.

OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on
days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients
are followed every 2 months for the first 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma (with
at least 25% oligodendroglial elements) Recurrent or progressive disease following both
radiotherapy and procarbazine/lomustine/vincristine chemotherapy (or other
nitrosoureas-based chemotherapy) Contrast enhancing, measurable disease (at least one
lesion measuring at least 1 cm) by CT or MRI required Within 2 weeks prior to study
treatment Within 3 days following concurrent surgery for the recurrence Steroid doses
stable or decreasing for at least 2 weeks prior to scan No extracranial disease

PATIENT CHARACTERISTICS: Age: 18-69 Performance status: WHO 0-2 Life expectancy: At least
3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal
(ULN) Alkaline phosphatase no greater than 2 times ULN AST/ALT no greater than 2 times ULN
Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance at least 60 mL/min
Other: Not pregnant or lactating Effective contraception required of fertile women No
diseases interfering with follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No more than one prior chemotherapy regimen At least 4 weeks since prior
chemotherapy Prior nitrosourea required At least 6 weeks since nitrosourea Endocrine
therapy: Not specified Radiotherapy: See Disease Characteristics More than 3 months since
radiotherapy Surgery: Not specified Other: No concurrent treatment with other
investigational agents or other antitumor agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin J. van Den Bent, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult oligodendroglioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms