Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme
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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 nitrocamptothecin in treating patients who have glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: rubitecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
| Enrollment: | 17 |
| Study Start Date: | March 2000 |
| Primary Completion Date: | September 2000 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| France | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre de Lute Contre le Cancer,Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Eugene Marquis | |
| Rennes, France, 35062 | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Italy | |
| Azienda Ospedaliera di Padova | |
| Padua, Italy, 35128 | |
| Netherlands | |
| Academisch Ziekenhuis der Vrije Universiteit | |
| Amsterdam, Netherlands, 1117 MB | |
| Spain | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Switzerland | |
| Ospedale San Giovanni | |
| Bellinzona, Switzerland, CH-6500 | |
| Clinique De Genolier | |
| Genolier, Switzerland, Ch-1272 | |
| Study Chair: | Eric Raymond, MD, PhD | Institut Gustave Roussy |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00005826 History of Changes |
| Other Study ID Numbers: | EORTC-16996G, EORTC-16996G |
| Study First Received: | June 2, 2000 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases 9-nitrocamptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013