- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00112476
Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors
A Phase I Study of Intravenous CCI-779 in Combination With Bryostatin-1 in Solid Tumors (10038414)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of temsirolimus when given together with bryostatin 1 in patients with unresectable or metastatic solid tumors.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Correlate the extent and duration of inhibition of p70^S6kinase phosphorylation in peripheral blood mononuclear cells with tumor growth or reduction in these patients.
II. Correlate the phosphorylation total and phospho-AKT and total and phospho ribosomal S6 protein (indicators of mTOR activation) with antitumor effects of this regimen in these patients.
III. Correlate tumor expression of phospho-ERK1 and -ERK2 with antitumor effects of this regimen in these patients.
IV. Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of temsirolimus.
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1. On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temsirolimus 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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19111-2497
- Fox Chase Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Histologically confirmed solid tumor, including melanoma or renal cell carcinoma
Metastatic or unresectable disease
- Must have evidence of residual, recurrent, or metastatic disease by radiography
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT scan, MRI, or x-ray) OR ≥ 10 mm by spiral CT scan
- Must show clear evidence of disease progression within the lesion if the only site of measurable disease is within a previously irradiated volume
- Standard curative or palliative measures do not exist OR are no longer effective
- No history of or known brain metastases
- Performance status - ECOG 0-1
- At least 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Fasting cholesterol ≤ 350 mg/dL*
- Triglycerides ≤ 400 mg/dL*
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception for ≥ 1 month before, during, and for ≥ 3 months after completion of study treatment (during and for ≥ 3 months after completion of study treatment for male patients)
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
- No ongoing or active bacterial or viral infection
- No psychiatric illness or social situation that would preclude study compliance
- No dementia or altered mental status that would preclude giving informed consent
- No other uncontrolled illnesses
- More than 3 weeks since prior immunotherapy
- Prior biological therapy (e.g., interferon or interleukin 2, vaccine, antibody-based and tyrosine kinase inhibitors) allowed
- No concurrent prophylactic hematopoietic colony-stimulating factors except for epoetin alfa
- No prior cytotoxic chemotherapy
- No prior bryostatin 1, temsirolimus, everolimus, or AP23573 for this malignancy
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No concurrent steroids except for topical or inhaled use
- No other concurrent experimental agents
- No prior radiotherapy to > 25% of bone marrow
- More than 3 weeks since prior radiotherapy
More than 3 weeks since prior major surgery, including nephrectomy
- Minor surgical procedures allowed
- Recovered from prior therapy
- More than 3 weeks since prior other anticancer investigational agents
- Concurrent CYP3A4 inducers or inhibitors allowed provided patient has been on a stable dose for ≥ 1 week before study entry
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent antineoplastic agents or therapies
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Treatment (bryostatin, temsirolimus)
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1.
On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dato IV
Altri nomi:
Dato IV
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
MTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0
Lasso di tempo: 28 days
|
A dose-limiting toxicity is defined as a toxicity that is >= grade 3 and drug-related.
|
28 days
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Changes in sum of RECIST measurements
Lasso di tempo: Baseline up to 30 days after completion of study treatment
|
Baseline up to 30 days after completion of study treatment
|
AKT activity, measured by immunohistochemistry (IHC), classified as none, weak, moderate, or strong
Lasso di tempo: Up to 30 days after completion of study treatment
|
Up to 30 days after completion of study treatment
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gary Hudes, Fox Chase Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urologiche
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie renali
- Malattie urologiche
- Adenocarcinoma
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Attributi della malattia
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Neoplasie renali
- Tumori neuroendocrini
- Nevi e melanomi
- Carcinoma, cellule renali
- Ricorrenza
- Melanoma
- Effetti fisiologici delle droghe
- Agenti antinfettivi
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antibatterici
- Adiuvanti, immunologici
- Antibiotici, Antineoplastici
- Agenti antimicotici
- Sirolimo
- Briostatina 1
Altri numeri di identificazione dello studio
- NCI-2011-01382
- 04-037
- FCCC-04037
- NCI-5785
- CDR0000432955
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su temsirolimus
-
Sheba Medical CenterStanley Medical Research InstituteSconosciutoSchizofrenia | Disturbo schizoaffettivoIsraele
-
St. Joseph's Healthcare HamiltonPfizer; McMaster UniversityCompletatoCarcinoma a cellule renaliCanada
-
AVEO Pharmaceuticals, Inc.Completato
-
New Mexico Cancer Care AllianceWyeth is now a wholly owned subsidiary of PfizerTerminato
-
Dana-Farber Cancer InstituteWyeth is now a wholly owned subsidiary of Pfizer; Millennium Pharmaceuticals,...Completato
-
Children's Hospital Medical Center, CincinnatiRitiratoLinfoma, cellule B | Leucemia, cellule BStati Uniti
-
Mathias Witzens-HarigCharite University, Berlin, Germany; Ludwig-Maximilians - University of Munich; Johann Wolfgang Goethe University Hospital e altri collaboratoriSconosciutoLinfoma diffuso a grandi cellule BGermania
-
Goethe UniversityCompletatoLeucemia mieloblastica acutaGermania
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Completato
-
M.D. Anderson Cancer CenterCompletato