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Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

14. september 2020 oppdatert av: Kathleen Phelan, Loyola University
This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

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

Intervensjonell

Registrering (Faktiske)

14

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Danielle Shafer, DO, Loyola University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2009

Primær fullføring (Faktiske)

1. oktober 2016

Studiet fullført (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først innsendt

6. februar 2009

Først innsendt som oppfylte QC-kriteriene

6. februar 2009

Først lagt ut (Anslag)

9. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2020

Sist bekreftet

1. september 2020

Mer informasjon

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. .

Kliniske studier på Temsirolimus

3
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