- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00006025
Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients With Recurrent Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan when administered with temozolomide in patients with recurrent malignant glioma.
- Determine the safety profile of this regimen in this patient population.
- Determine the efficacy of this treatment regimen as measured by 6-month progression-free survival and objective tumor response in these patients.
- Characterize the pharmacokinetics of this treatment regimen in these patients.
- Determine the antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, phenobarbital, carbamazepine, or primidone) (yes vs no).
In phase I of the study, patients receive oral temozolomide on days 1-5 and irinotecan IV over 90 minutes on days 1 and 14. Treatment continues every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients concurrently on EIAEDs undergo dose escalation of irinotecan. Cohorts of 3 to 6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
In phase II of the study, patients receive the same treatment as in phase I at the MTD.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months until progression, and then every 4 months for survival.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I within 10 months and 48 patients will be accrued for phase II within 6-8 months.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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California
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Los Angeles, California, Vereinigte Staaten, 90095
- Jonsson Comprehensive Cancer Center, UCLA
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San Francisco, California, Vereinigte Staaten, 94143
- UCSF Comprehensive Cancer Center
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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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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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New York
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New York, New York, Vereinigte Staaten, 10021
- Memorial Sloan-Kettering Cancer Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Texas
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Houston, Texas, Vereinigte Staaten, 77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Vereinigte Staaten, 78284-6220
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53792
- University of Wisconsin Comprehensive Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial malignant primary glioma of one of the following subtypes:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Mixed malignant glioma
- Original histology of low-grade glioma allowed if subsequent histological confirmation of malignant glioma
Measurable recurrent or residual primary disease by MRI
- Lesions with clearly defined margins
- Evidence of tumor recurrence or progression by MRI or CT scan
- Confirmation of true progressive disease by PET or thallium scan, magnetic resonance spectroscopy, or surgical documentation after prior interstitial brachytherapy or stereotactic radiosurgery
- No more than 3 relapses after prior chemotherapy/cytotoxic therapy (including polifeprosan 20 with carmustine implant) for phase I and no more than 2 relapses for phase II
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmia
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No mental incapacitation
- HIV negative
- No AIDS-related disease
- No significant ongoing alcoholism or substance abuse
- No severe nonmalignant systemic disease
- No active infection
- No other severe disease that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior interferon or thalidomide and recovered
- No concurrent anticancer immunotherapy
- No concurrent sargramostim (GM-CSF)
- No concurrent prophylactic filgrastim (G-CSF) during first course of study therapy
Chemotherapy:
- See Disease Characteristics
- Recovered from prior chemotherapy
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosourea)
- Prior radiosensitizers allowed
- No prior temozolomide or irinotecan
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- At least 1 week since prior tamoxifen and recovered
- No concurrent anticancer hormonal therapy
Phase II:
- Non-increasing dose of corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent anticancer radiotherapy
Surgery:
- See Disease Characteristics
- At least 1-3 weeks since prior surgical resection and recovered
Other:
- At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) and recovered
- Concurrent enzyme-inducing anti-epileptic drugs with or without steroids allowed
- No concurrent valproic acid as a single agent
- No concurrent medication that would preclude study (e.g., nonsteroidal immunosuppressive agents)
- No other concurrent investigational drugs
- No concurrent participation in other clinical study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Wai-Kwan A. Yung, MD, M.D. Anderson Cancer Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
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
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Topoisomerase-Inhibitoren
- Topoisomerase I-Inhibitoren
- Temozolomid
- Irinotecan
Andere Studien-ID-Nummern
- NABTC-9907
- CDR0000068037 (Registrierungskennung: PDQ (Physician Data Query))
- UCLA-0006095
- NCI-2012-02353 (Registrierungskennung: CTRP (Clinical Trials Reporting System))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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