Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003304
First received: November 1, 1999
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 29
Study Start Date: April 1998
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003304

  Show 37 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Martin J. van Den Bent, MD Daniel Den Hoed Cancer Center at Erasmus Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003304     History of Changes
Other Study ID Numbers: EORTC-26972, EORTC-26972
Study First Received: November 1, 1999
Last Updated: March 5, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult oligodendroglioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014