Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme

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 nitrocamptothecin in treating patients who have glioblastoma multiforme.

Study Overview

Status

Completed

Conditions

Brain and Central Nervous System Tumors

Intervention / Treatment

Drug: rubitecan

Detailed Description

OBJECTIVES: I. Assess the therapeutic activity and toxicities of nitrocamptothecin in patients with glioblastoma multiforme. II. Determine the overall response, duration of response, and progression free survival of these patients after this treatment.

OUTLINE: This is a multicenter study. Patients receive nitrocamptothecin orally daily on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression in the absence of further treatment.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Edegem, Belgium, B-2650
    - Universitair Ziekenhuis Antwerpen
France
- - Clermont-Ferrand, France, 63011
    - Centre Jean PERRIN
  - Dijon, France, 21079
    - Centre de Lute Contre le Cancer,Georges-Francois Leclerc
  - Lyon, France, 69373
    - Centre Leon Berard
  - Nantes-Saint Herblain, France, 44805
    - CRLCC Nantes - Atlantique
  - Rennes, France, 35062
    - Centre Eugene Marquis
  - Rouen, France, 76038
    - Centre Henri Becquerel
  - Villejuif, France, F-94805
    - Institut Gustave Roussy
Italy
- - Padua, Italy, 35128
    - Azienda Ospedaliera Di Padova
Netherlands
- - Amsterdam, Netherlands, 1117 MB
    - Academisch Ziekenhuis der Vrije Universiteit
Spain
- - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
Switzerland
- - Bellinzona, Switzerland, CH-6500
    - Ospedale San Giovanni
  - Genolier, Switzerland, Ch-1272
    - Clinique de Genolier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed glioblastoma multiforme Recurrent disease confirmed by CT or MRI Bidimensionally measurable disease At least one lesion with the largest diameter at least 2 cm

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of ischemic heart disease in past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior or concurrent malignancies except cone biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma No other unstable systemic disease No active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior adjuvant chemotherapy No other prior or concurrent chemotherapy allowed Endocrine therapy: Concurrent corticosteroids allowed Stable or decreasing dose for at least 2 weeks Radiotherapy: No high dose radiotherapy, stereotactic radiosurgery, or internal radiotherapy unless recurrence is histologically confirmed At least 3 months since prior radiotherapy to the brain Surgery: No prior surgery for recurrent brain tumor except biopsy At least 3 months since prior surgery for primary brain tumor Other: No other concurrent anticancer therapy No other concurrent investigational therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair: Eric Raymond, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

September 1, 2000

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

June 17, 2004

First Posted (Estimate)

June 18, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EORTC-16996G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.