- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00838955
Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Studieoversikt
Detaljert beskrivelse
Temsirolimus 25 mg IV infusion will be given once weekly on days 1, 8, 15 and 22 of each cycle. Patients will be assessed for response with CT scans after the second cycle, and then after every other cycle until disease progression is confirmed.
Patients will be treated with Temsirolimus until disease progression, or up to six cycles. Continuation of therapy beyond cycles is at the discretion of the investigator.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Maywood, Illinois, Forente stater, 60153
- Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically confirmed classical Hodgkin Lymphoma or Lymphocyte Predominant Hodgkin Lymphoma with progressive disease during or at the end of the previous therapy, as defined by the IWG criteria.
- Patient must have nodular sclerosing, lymphocyte depleted, or mixed cellularity Hodgkin Lymphoma (Classical Hodgkin Lymphoma), or Lymphocyte predominant Hodgkin Lymphoma.
- Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
- Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging.
- A clearly defined, bidimensionally measurable lymph node or tumor mass measuring at least 2 cm in diameter on a CT scan.
- Patient should have had at least one line of prior chemotherapy. Patients relapsing after treatment with radiation therapy alone are not eligible.
- Age > than or equal to 18 years.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
- Women must not be pregnant or breast-feeding due to lack of information about the safety of administration of Temsirolimus in pregnant and lactating patients. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of pregnancy prevention.
- Patient must have a SWOG performance status between 0-2.
- Patient must have no prior treatment with an m-TOR inhibitor.
- Patient must not have active infections at the time of registration.
- Laboratory studies should be obtained within two weeks of study registration except where noted otherwise. Allowable laboratory values are listed below:
- Absolute neutrophil count > than or equal 1,000/mm3
- Hemoglobin > than or equal 8 gm/dL
- Platelets > than or equal 75,000/mm3
- Serum creatinine < than or equal to two times the upper limit of normal. Creatinine should be measured within seven days of registration.
- Total serum bilirubin < than or equal to ≤ 1.5 times the upper limit of normal. Total bilirubin should be measured within seven days of registration.
- AST (SGOT) < than or equal to 3 times the upper limit of normal.
- ALT (SGPT) < than or equal to 3 times the upper limit of normal.
- Fasting total cholesterol < than or equal to 350 mg/dL.
- Fasting triglyceride level < than or equal to 400 mg/dL.
- Patient must have a life expectancy of three months.
Exclusion Criteria:
- Patient must not have received prior allogeneic stem cell transplantation. Prior autologous stem cell transplantation more than six months prior to registration is acceptable.
- Patient must not have received prior chemotherapy, biologic therapy or radiation within three weeks prior to registration, and should have recovered from toxicities of prior therapy (to Grade 0 or 1).
- Patient must not have evidence of active CNS disease.
- Patient must not have an uncontrolled comorbid disease, including hyperlipidemia, hypertriglyceridemia, diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Patient must not have a psychiatric illness or social situation that would limit compliance with study requirements.
- Patient must have a life expectancy of three months.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Temsirolimus
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
|
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus
Tidsramme: 26 weeks
|
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus
|
26 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To evaluate the toxicity of temsirolimus in this patient population.
Tidsramme: 26 weeks
|
To evaluate the toxicity of temsirolimus in this patient population.
|
26 weeks
|
To estimate the time to progression after treatment with temsirolimus.
Tidsramme: 5 years
|
To estimate the time to progression after treatment with temsirolimus.
|
5 years
|
To estimate overall survival after treatment with temsirolimus.
Tidsramme: 5 years
|
To estimate overall survival after treatment with temsirolimus.
|
5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Danielle Shafer, DO, Loyola University
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 (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom
- Hodgkins sykdom
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Sirolimus
Andre studie-ID-numre
- 201170
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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