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Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

26. oktober 2020 opdateret af: Martha Wadleigh, M.D., Dana-Farber Cancer Institute

Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate

RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.
  • Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.

Secondary

  • Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.
  • Determine the development of tumor immunity in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of GM-K562.

Patients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 20 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana Farber Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic myelogenous leukemia

    • Chronic phase disease
    • Philadelphia chromosome positive disease
  • Disease in first complete hematologic response, defined by all of the following:

    • Complete normalization of peripheral blood counts with WBC < 10,000/mm^3
    • Platelet count < 450,000/mm^3
    • No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
  • Persistent molecular evidence of disease

    • Detectable BCR-ABL transcript by quantitative polymerase chain reaction
    • Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
  • Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • No known HIV
  • ALT or AST ≤ 3 times upper limit of normal
  • Oxygen saturation ≥ 93% at room air
  • No history of recent acute myocardial infarction
  • No history of unstable angina
  • No pulmonary decomposition requiring hospitalization within the past 3 months
  • No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior allogeneic stem cell transplantation
  • At least 2 months since other prior experimental therapy
  • At least 6 months since prior participation in another vaccine study
  • No concurrent systemic immunosuppressive medication

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and Toxicity
Tidsramme: 3 years
To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Response
Tidsramme: 3 years
To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements
3 years
Tumor immunity
Tidsramme: 3 years
To characterize the development of tumor immunity in response to vaccination with GM-K562 cells
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

10. september 2020

Datoer for studieregistrering

Først indsendt

8. marts 2006

Først indsendt, der opfyldte QC-kriterier

8. marts 2006

Først opslået (Skøn)

10. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med GM-K562 cell vaccine

3
Abonner