- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111-2497
- Fox Chase Cancer Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Givet IV
Andra namn:
Givet IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
MTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Changes in sum of RECIST measurements
Tidsram: 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
Tidsram: Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gary Hudes, Fox Chase Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urologiska neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Njursjukdomar
- Urologiska sjukdomar
- Adenocarcinom
- Carcinom
- Neoplasmer, körtel och epitel
- Sjukdomsegenskaper
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neoplasmer i njurarna
- Neuroendokrina tumörer
- Nevi och melanom
- Karcinom, njurcell
- Upprepning
- Melanom
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antibakteriella medel
- Adjuvans, immunologiska
- Antibiotika, antineoplastiska
- Antifungala medel
- Sirolimus
- Bryostatin 1
Andra studie-ID-nummer
- NCI-2011-01382
- 04-037
- FCCC-04037
- NCI-5785
- CDR0000432955
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