Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005826
• Other study ID #: EORTC-16996G
• Secondary ID: EORTC-16996G
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: September 20, 2012
• Start date: March 2000

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• rubitecan

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon
France	Centre Leon Berard	Lyon
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Institut Gustave Roussy	Villejuif
Italy	Azienda Ospedaliera di Padova	Padua
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Clinique De Genolier	Genolier

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Netherlands,  Spain,  Switzerland,