- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00074243
CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas
RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas.
- Determine, preliminarily, the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine, preliminarily, the potential anti-glioma activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose.
Patients are followed within 2 weeks.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial malignant glioma, including any of the following:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant glioma/astrocytoma not otherwise specified OR
- Clinical and radiographic diagnosis of progressive low-grade glioma
- Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed
Recurrent or progressive disease as determined by 1 of the following:
- CT scan or MRI within the past 21 days
- Biopsy within the past 12 weeks
- Failed prior radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- More than 8 weeks
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 2 times upper limit of normal
- No significant active hepatic disease that would preclude study participation
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No significant active renal disease that would preclude study participation
Cardiovascular
- No significant active cardiac disease that would preclude study participation
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No significant active psychiatric disease that would preclude study participation
- No other condition or laboratory abnormality that would preclude study participation
- Able to swallow capsules whole
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 2 weeks since prior interferon
- No concurrent immunotherapy
Chemotherapy
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 4 weeks since prior temozolomide or carboplatin
- At least 6 weeks since prior nitrosoureas
- No other concurrent anticancer chemotherapy
Endocrine therapy
- At least 2 weeks since prior tamoxifen
- Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment
Radiotherapy
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 2 weeks since prior resection of a recurrent or progressive tumor
Other
- At least 2 weeks since other prior non-cytotoxic therapy
- At least 4 weeks since other prior cytotoxic therapies
- More than 28 days since prior experimental study drugs
- No other concurrent investigational agents
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Howard A. Fine, MD, NCI - Neuro-Oncology Branch
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Neubildungen, Drüsen und Epithelien
- Neubildungen, Neuroepithel
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Gliom
- Neubildungen des Nervensystems
- Neubildungen des zentralen Nervensystems
Andere Studien-ID-Nummern
- CDR0000343702
- NCI-04-C-0035
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