- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90095
- Jonsson Comprehensive Cancer Center, UCLA
-
-
New York
-
New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium IV nyrecellekræft
- tilbagevendende nyrecellekræft
- stadium IV brystkræft
- stadium IIIA brystkræft
- tilbagevendende brystkræft
- stadium IIIB brystkræft
- tilbagevendende ikke-småcellet lungekræft
- stadium III blærekræft
- tilbagevendende blærekræft
- stadium IV blærekræft
- stadium III prostatacancer
- stadium IV prostatacancer
- tilbagevendende prostatakræft
- fase IIIA ikke-småcellet lungekræft
- stadium IIIB ikke-småcellet lungekræft
- fase IV ikke-småcellet lungekræft
- uspecificeret voksen solid tumor, protokol specifik
- ubehandlet metastatisk planehalskræft med okkult primær
- tilbagevendende metastatisk planehalskræft med okkult primær
- stadium III planocellulært karcinom i læben og mundhulen
- stadium III basalcellekarcinom i læben
- stadium III verrucous carcinom i mundhulen
- stadium III mucoepidermoid karcinom i mundhulen
- stadium III adenoid cystisk carcinom i mundhulen
- stadium IV planocellulært karcinom i læben og mundhulen
- stadium IV basalcellekarcinom i læben
- stadium IV verrucous carcinom i mundhulen
- stadium IV mucoepidermoid karcinom i mundhulen
- stadium IV adenoid cystisk carcinom i mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- tilbagevendende basalcellekarcinom i læben
- tilbagevendende verrucous carcinom i mundhulen
- tilbagevendende mucoepidermoid karcinom i mundhulen
- tilbagevendende adenoid cystisk carcinom i mundhulen
- stadium III planocellulært karcinom i oropharynx
- stadium III lymfepitheliom i oropharynx
- stadium IV planocellulært karcinom i oropharynx
- stadium IV lymfepitheliom i oropharynx
- tilbagevendende pladecellekarcinom i oropharynx
- tilbagevendende lymfepitheliom i oropharynx
- stadium III planocellulært karcinom i nasopharynx
- stadium III lymfepitheliom i nasopharynx
- stadium IV planocellulært karcinom i nasopharynx
- stadium IV lymfepitheliom i nasopharynx
- tilbagevendende pladecellekarcinom i nasopharynx
- tilbagevendende lymfepitheliom i nasopharynx
- stadium III planocellulært karcinom i hypopharynx
- stadium IV planocellulært karcinom i hypopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- stadium III planocellulært karcinom i strubehovedet
- stadium III verrucous carcinom i strubehovedet
- stadium IV planocellulært karcinom i strubehovedet
- stadium IV verrucous carcinom i strubehovedet
- tilbagevendende pladecellekarcinom i strubehovedet
- tilbagevendende verrucous carcinom i strubehovedet
- stadium III planocellulært karcinom i paranasale sinus og næsehulen
- stadium III midtlinje letalt granulom i paranasal sinus og næsehulen
- stadium III esthesioneuroblastoma i paranasale sinus og næsehulen
- stadium IV planocellulært karcinom i paranasale sinus og næsehulen
- stadium IV midtlinje letalt granulom i paranasal sinus og næsehulen
- stadium IV esthesioneuroblastoma i paranasal sinus og næsehulen
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
- tilbagevendende middellinje letalt granulom i paranasale sinus og næsehulen
- tilbagevendende esthesioneuroblastom i paranasale sinus og næsehulen
- tilbagevendende spytkirtelkræft
- stadium III spytkirtelkræft
- stadium IV spytkirtelkræft
- stadium IV tyktarmskræft
- tilbagevendende tyktarmskræft
- stadium III ovarieepitelkræft
- stadium IV ovarieepitelkræft
- tilbagevendende ovarieepitelkræft
- stadium III tyktarmskræft
- stadium IIIC brystkræft
- tilbagevendende melanom
- stadium IV melanom
- kronisk fase kronisk myelogen leukæmi
- blastisk fase kronisk myelogen leukæmi
- recidiverende kronisk myelogen leukæmi
- stadium IV gastrisk cancer
- tilbagevendende mavekræft
- stadium III nyrecellekræft
- stadium III melanom
- stadium III mavekræft
- tilbagevendende akut lymfatisk leukæmi hos voksne
- ovariesarkom
- accelereret fase kronisk myelogen leukæmi
- borderline ovarieoverflade epitel-stromal tumor
- ovariestromal cancer
- tilbagevendende ovarie-kimcelletumor
- stadium III ovarie-kimcelletumor
- stadium IV ovarie-kimcelletumor
- tilbagevendende omvendt papilloma i paranasale sinus og næsehulen
- stadium III inverteret papilloma i paranasal sinus og næsehulen
- stadium IV inverteret papilloma i paranasale sinus og næsehulen
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Hudsygdomme
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Lungesygdomme
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Urologiske sygdomme
- Urinblæresygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Genitale neoplasmer, mandlige
- Brystsygdomme
- Prostatasygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Neoplasmer i maven
- Brystneoplasmer
- Neoplasmer i hoved og hals
- Prostatiske neoplasmer
- Lungeneoplasmer
- Leukæmi
- Urinblære neoplasmer
- Melanom
Andre undersøgelses-id-numre
- 99-037
- CDR0000067267 (Registry Identifier: PDQ (Physician Data Query))
- NCI-T99-0035
- UCLA-0206019
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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-
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-
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-
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-
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-
National Cancer Institute (NCI)AfsluttetStadie IV brystkræft | Stadie IIIB brystkræft | Stadie IIIC brystkræft | Tilbagevendende brystkræftForenede Stater
-
National Cancer Institute (NCI)AfsluttetTilbagevendende prostatakræft | Adenocarcinom i prostata | Stadie IV prostatakræftForenede Stater
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