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- Klinische proef NCT00004065
Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with refractory or advanced solid tumors or hematologic malignancies.
- Evaluate the effects of this drug on the expression of signaling proteins present on an individual patient's cancer at the start of treatment and, if possible, post treatment.
OUTLINE: This is a two-phase, dose-escalation, multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia [CML] or Philadelphia chromosome [Ph]+ acute lymphoblastic leukemia [ALL] vs solid tumor).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes twice weekly. Courses repeat every 12 weeks in the absence of disease progression (after at least 2 courses for CML or Ph+ ALL patients) or unacceptable toxicity.
- Accelerated phase: Single patients receive escalating dose levels of 17-AAG until one patient experiences a first course grade 3 or greater toxicity or two different patients experience grade 2 toxicity during any course.
- Standard phase: Cohorts of 3-6 patients in each stratum receive escalating doses of 17-AAG 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.
PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.
Studietype
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90095
- Jonsson Comprehensive Cancer Center, UCLA
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists
Progressive disease evidenced by 1 of the following:
Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma)
- Development of new lesions or an increase in existing lesions
- No increase in a biochemical marker (e.g., carcinoembryonic antigen, CA-15-3, or an increase in symptoms) as sole measure of disease
Prostate cancer (androgen independent) meeting the following criteria:
- Progressing metastatic disease on bone scan, CT scan, or MRI
Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria:
- At least 3 rising PSA values obtained at least 1 week apart = 2 rising values more than 1 month apart with at least 25% increase over the range of values
- Serum testosterone less than 30 ng/mL
- Castrate status should be maintained by medical therapies if orchiectomy has not been performed
- Progressive disease must be evident off antiandrogen therapy if received prior to study entry
- Registered to protocol MSKCC-9040
Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists
Progressive disease evidenced by 1 of the following:
- Accelerated or blastic phase disease that is not responsive to standard therapy or loss of hematologic response to imatinib mesylate while remaining in chronic phase for CML
- Relapsed or refractory after treatment with standard chemotherapy and imatinib mesylate for Ph-positive ALL
- No active CNS or epidural tumor
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 6 months
Hematopoietic:
- WBC greater than 3,500/mm^3
- Platelet count greater than 100,000/mm^3
- No restrictions based on peripheral blood counts for CML and Ph-positive ALL
Hepatic:
- Bilirubin no greater than 1.2 times upper limit of normal (ULN)
- AST less than 1.5 times ULN
- Prothrombin time normal
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No myocardial infarction within the past 6 months
- Ejection fraction greater than 45% by radionuclide cardiac angiography
- No ventricular aneurysm or other abnormal wall motion
No reversible defect by thallium stress test if any of the following conditions are present:
- Ejection fraction less than 45% on radionuclide angiocardiography
- Worrisome but nonexclusive cardiovascular history
- Abnormal echocardiogram
Patients with the following history or clinical findings require additional diagnostic testing:
- Significant Q waves (greater than 3 mm or greater than one-third of the height of the QRS complex)
- ST elevation or depressions of greater than 2 mm that are not attributable to hypertension strain
- Absence of regular sinus rhythm
- Bundle branch block
- Requirement for diuretics for reasons other than hypertension or digoxin for reasons other than atrial fibrillation
- Prior mild to moderate congestive heart failure
- No New York Heart Association class III or IV heart disease
- No angina pectoris
- No uncontrolled hypertension or intermittent claudication
- No severe debilitating valvular disease
Pulmonary:
- No severe debilitating pulmonary disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring IV antibiotics
- No symptomatic peripheral neuropathy grade 2 or higher
- No other severe medical conditions that would increase risk for toxicity
- No allergy to eggs or egg products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy (including interferon for CML) and recovered
Chemotherapy:
- At least 4 weeks since prior chemotherapy (3 days for hydroxyurea for CML or ALL) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since prior endocrine therapy and recovered
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent radiotherapy to localized disease sites not being used to evaluate antitumor response allowed
- No concurrent radiotherapy to only measurable lesion
Surgery:
- See Disease Characteristics
- Prior orchiectomy allowed
- No concurrent surgery
Other:
- At least 3 days since prior imatinib mesylate for CML or ALL
- At least 4 weeks since prior investigational anticancer drugs and recovered
- At least 4 weeks since prior palliative treatment for metastatic disease
- No concurrent ketoconazole, warfarin, verapamil, miconazole, or erythromycin
- No other concurrent investigational drugs
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- stadium IV niercelkanker
- recidiverende niercelkanker
- stadium IV borstkanker
- stadium IIIA borstkanker
- terugkerende borstkanker
- stadium IIIB borstkanker
- recidiverende niet-kleincellige longkanker
- stadium III blaaskanker
- terugkerende blaaskanker
- stadium IV blaaskanker
- stadium III prostaatkanker
- stadium IV prostaatkanker
- terugkerende prostaatkanker
- stadium IIIA niet-kleincellige longkanker
- stadium IIIB niet-kleincellige longkanker
- stadium IV niet-kleincellige longkanker
- niet-gespecificeerde volwassen solide tumor, protocolspecifiek
- onbehandelde gemetastaseerde plaveiselhalskanker met occulte primaire
- recidiverende uitgezaaide plaveiselhalskanker met occult primair
- stadium III plaveiselcelcarcinoom van de lip en mondholte
- stadium III basaalcelcarcinoom van de lip
- stadium III verrukeus carcinoom van de mondholte
- stadium III mucoepidermoïde carcinoom van de mondholte
- stadium III adenoïd cystisch carcinoom van de mondholte
- stadium IV plaveiselcelcarcinoom van de lip en mondholte
- stadium IV basaalcelcarcinoom van de lip
- stadium IV verrukeus carcinoom van de mondholte
- stadium IV mucoepidermoïde carcinoom van de mondholte
- stadium IV adenoïd cystisch carcinoom van de mondholte
- recidiverend plaveiselcelcarcinoom van de lip en mondholte
- terugkerend basaalcelcarcinoom van de lip
- recidiverend verrukeus carcinoom van de mondholte
- recidiverend mucoepidermoïd carcinoom van de mondholte
- recidiverend adenoïd cystisch carcinoom van de mondholte
- stadium III plaveiselcelcarcinoom van de orofarynx
- stadium III lymfoepithelioom van de orofarynx
- stadium IV plaveiselcelcarcinoom van de orofarynx
- stadium IV lymfoepithelioom van de orofarynx
- recidiverend plaveiselcelcarcinoom van de orofarynx
- recidiverend lymfoepithelioom van de orofarynx
- stadium III plaveiselcelcarcinoom van de nasopharynx
- stadium III lymfoepithelioom van de nasopharynx
- stadium IV plaveiselcelcarcinoom van de nasopharynx
- stadium IV lymfoepithelioom van de nasopharynx
- recidiverend plaveiselcelcarcinoom van de nasopharynx
- recidiverend lymfoepithelioom van de nasopharynx
- stadium III plaveiselcelcarcinoom van de hypofarynx
- stadium IV plaveiselcelcarcinoom van de hypofarynx
- recidiverend plaveiselcelcarcinoom van de hypofarynx
- stadium III plaveiselcelcarcinoom van het strottenhoofd
- stadium III verrukeus carcinoom van het strottenhoofd
- stadium IV plaveiselcelcarcinoom van het strottenhoofd
- stadium IV verrukeus carcinoom van het strottenhoofd
- recidiverend plaveiselcelcarcinoom van het strottenhoofd
- recidiverend verrukeus carcinoom van het strottenhoofd
- stadium III plaveiselcelcarcinoom van de neusbijholten en de neusholte
- stadium III middellijn dodelijk granuloom van de neusbijholten en de neusholte
- stadium III esthesioneuroblastoma van de neusbijholten en de neusholte
- stadium IV plaveiselcelcarcinoom van de neusbijholte en de neusholte
- stadium IV middellijn dodelijk granuloom van de neusbijholten en de neusholte
- stadium IV esthesioneuroblastoom van de neusbijholten en de neusholte
- recidiverend plaveiselcelcarcinoom van de neusbijholten en de neusholte
- recidiverend middellijn dodelijk granuloom van de neusbijholten en de neusholte
- recidiverend esthesioneuroblastoom van de neusbijholten en de neusholte
- terugkerende speekselklierkanker
- stadium III speekselklierkanker
- stadium IV speekselklierkanker
- stadium IV darmkanker
- recidiverende darmkanker
- stadium III eierstokepitheelkanker
- stadium IV eierstokepitheelkanker
- recidiverende eierstokepitheelkanker
- darmkanker stadium III
- stadium IIIC borstkanker
- terugkerend melanoom
- stadium IV melanoom
- chronische fase chronische myeloïde leukemie
- blastische fase chronische myeloïde leukemie
- recidiverende chronische myeloïde leukemie
- stadium IV maagkanker
- terugkerende maagkanker
- stadium III niercelkanker
- stadium III melanoom
- stadium III maagkanker
- recidiverende volwassen acute lymfatische leukemie
- ovarium sarcoom
- versnelde fase chronische myeloïde leukemie
- borderline eierstokoppervlak epitheel-stromale tumor
- stromale kanker van de eierstokken
- recidiverende ovariumkiemceltumor
- stadium III eierstokkiemceltumor
- stadium IV eierstokkiemceltumor
- recidiverend omgekeerd papilloom van de neusbijholten en de neusholte
- stadium III omgekeerd papilloma van de neusbijholten en de neusholte
- stadium IV omgekeerd papilloma van de neusbijholten en de neusholte
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Huidziektes
- Ziekten van de luchtwegen
- Neoplasmata per histologisch type
- Neoplasmata
- Longziekten
- Urologische neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Urologische ziekten
- Ziekten van de urineblaas
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Genitale neoplasmata, mannelijk
- Borst ziekten
- Prostaat Ziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-endocriene tumoren
- Nevi en melanomen
- Maagneoplasmata
- Borstneoplasmata
- Hoofd- en nekneoplasmata
- Prostaatneoplasmata
- Longneoplasmata
- Leukemie
- Neoplasmata van de urineblaas
- Melanoma
Andere studie-ID-nummers
- 99-037
- CDR0000067267 (Register-ID: PDQ (Physician Data Query))
- NCI-T99-0035
- UCLA-0206019
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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