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- Klinische proef 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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19111-2497
- Fox Chase 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
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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IV gegeven
Andere namen:
IV gegeven
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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MTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0
Tijdsspanne: 28 days
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A dose-limiting toxicity is defined as a toxicity that is >= grade 3 and drug-related.
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28 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Changes in sum of RECIST measurements
Tijdsspanne: Baseline up to 30 days after completion of study treatment
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Baseline up to 30 days after completion of study treatment
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AKT activity, measured by immunohistochemistry (IHC), classified as none, weak, moderate, or strong
Tijdsspanne: Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gary Hudes, Fox Chase Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire 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
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata per histologisch type
- Neoplasmata
- Urologische neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Nier Ziekten
- Urologische ziekten
- Adenocarcinoom
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Ziekte attributen
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Nierneoplasmata
- Neuro-endocriene tumoren
- Nevi en melanomen
- Carcinoom, niercel
- Herhaling
- Melanoma
- Fysiologische effecten van medicijnen
- Anti-infectieuze middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antibacteriële middelen
- Adjuvantia, immunologisch
- Antibiotica, antineoplastiek
- Antischimmelmiddelen
- Sirolimus
- Bryostatine 1
Andere studie-ID-nummers
- NCI-2011-01382
- 04-037
- FCCC-04037
- NCI-5785
- CDR0000432955
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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