- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
California
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Los Angeles, California, Forente stater, 90095
- Jonsson Comprehensive Cancer Center, UCLA
-
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New York
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- stadium IV nyrecellekreft
- tilbakevendende nyrecellekreft
- stadium IV brystkreft
- stadium IIIA brystkreft
- tilbakevendende brystkreft
- stadium IIIB brystkreft
- tilbakevendende ikke-småcellet lungekreft
- stadium III blærekreft
- tilbakevendende blærekreft
- stadium IV blærekreft
- stadium III prostatakreft
- stadium IV prostatakreft
- tilbakevendende prostatakreft
- stadium IIIA ikke-småcellet lungekreft
- stadium IIIB ikke-småcellet lungekreft
- stadium IV ikke-småcellet lungekreft
- uspesifisert voksen solid svulst, protokollspesifikk
- ubehandlet metastatisk plateepitelkreft med okkult primær
- tilbakevendende metastatisk plateepitelkreft med okkult primær
- stadium III plateepitelkarsinom i leppe og munnhule
- stadium III basalcellekarsinom i leppen
- stadium III verrucous karsinom i munnhulen
- stadium III mucoepidermoid karsinom i munnhulen
- stadium III adenoid cystisk karsinom i munnhulen
- stadium IV plateepitelkarsinom i leppe og munnhule
- stadium IV basalcellekarsinom i leppen
- stadium IV verrucous karsinom i munnhulen
- stadium IV mucoepidermoid karsinom i munnhulen
- stadium IV adenoid cystisk karsinom i munnhulen
- tilbakevendende plateepitelkarsinom i leppe og munnhule
- tilbakevendende basalcellekarsinom i leppen
- tilbakevendende verrucous karsinom i munnhulen
- tilbakevendende mucoepidermoid karsinom i munnhulen
- tilbakevendende adenoid cystisk karsinom i munnhulen
- stadium III plateepitelkarsinom i orofarynx
- stadium III lymfepitelom i orofarynx
- stadium IV plateepitelkarsinom i orofarynx
- stadium IV lymfepitheliom i orofarynx
- tilbakevendende plateepitelkarsinom i orofarynx
- tilbakevendende lymfepitelom i orofarynx
- stadium III plateepitelkarsinom i nasopharynx
- stadium III lymfepitelom i nasofarynx
- stadium IV plateepitelkarsinom i nasopharynx
- stadium IV lymfepitheliom i nasofarynx
- tilbakevendende plateepitelkarsinom i nasopharynx
- tilbakevendende lymfepitheliom i nasofarynx
- stadium III plateepitelkarsinom i hypopharynx
- stadium IV plateepitelkarsinom i hypopharynx
- tilbakevendende plateepitelkarsinom i hypopharynx
- stadium III plateepitelkarsinom i strupehodet
- stadium III verrucous karsinom i strupehodet
- stadium IV plateepitelkarsinom i strupehodet
- stadium IV verrucous karsinom i strupehodet
- tilbakevendende plateepitelkarsinom i strupehodet
- tilbakevendende verrucous karsinom i strupehodet
- stadium III plateepitelkarsinom i paranasal sinus og nesehulen
- stadium III midtlinje letal granulom i paranasal sinus og nesehulen
- stadium III estesioneuroblastoma i paranasal sinus og nesehulen
- stadium IV plateepitelkarsinom i paranasal sinus og nesehulen
- stadium IV midtlinje letal granulom av paranasal sinus og nesehulen
- stadium IV esthesioneuroblastoma i paranasal sinus og nesehulen
- tilbakevendende plateepitelkarsinom i paranasal sinus og nesehulen
- tilbakevendende middellinje letal granulom i paranasal sinus og nesehulen
- tilbakevendende estesioneuroblastom i paranasal sinus og nesehulen
- tilbakevendende spyttkjertelkreft
- stadium III spyttkjertelkreft
- stadium IV spyttkjertelkreft
- stadium IV tykktarmskreft
- tilbakevendende tykktarmskreft
- stadium III eggstokepitelkreft
- stadium IV eggstokepitelkreft
- tilbakevendende eggstokepitelkreft
- stadium III tykktarmskreft
- stadium IIIC brystkreft
- tilbakevendende melanom
- stadium IV melanom
- kronisk fase kronisk myelogen leukemi
- blastisk fase kronisk myelogen leukemi
- tilbakefallende kronisk myelogen leukemi
- stadium IV magekreft
- tilbakevendende magekreft
- stadium III nyrecellekreft
- stadium III melanom
- stadium III magekreft
- tilbakevendende akutt lymfatisk leukemi hos voksne
- eggstokksarkom
- akselerert fase kronisk myelogen leukemi
- borderline ovarieoverflate epitel-stromal tumor
- stromakreft i eggstokkene
- tilbakevendende kimcelletumor i eggstokkene
- stadium III eggstokkkimcelletumor
- stadium IV eggstokkkimcelletumor
- tilbakevendende invertert papillom i paranasal sinus og nesehulen
- stadium III invertert papilloma i paranasal sinus og nesehulen
- stadium IV invertert papilloma i paranasal sinus og nesehulen
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Hudsykdommer
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer
- Lungesykdommer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Urologiske sykdommer
- Urinblæresykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Genitale neoplasmer, hanner
- Bryst sykdommer
- Prostata sykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nevroendokrine svulster
- Nevi og melanomer
- Neoplasmer i magen
- Brystneoplasmer
- Neoplasmer i hode og nakke
- Prostatiske neoplasmer
- Lungeneoplasmer
- Leukemi
- Neoplasmer i urinblæren
- Melanom
Andre studie-ID-numre
- 99-037
- CDR0000067267 (Registeridentifikator: PDQ (Physician Data Query))
- NCI-T99-0035
- UCLA-0206019
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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