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Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma

12. maj 2010 opdateret af: Fred Hutchinson Cancer Center

A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapies such as interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or lymphoma.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the toxicity of sargramostim (GM-CSF) and filgrastim (G-CSF)-mobilized interleukin-2(IL-2)-incubated autologous peripheral blood stem cells and sequential IL-2 in patients with solid tumors or lymphoma.
  • Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF to mobilize adequate numbers of CD34+ cells and immune cells in these patients.
  • Determine the time to neutrophil and platelet engraftment in patients treated with this regimen.
  • Determine the overall and disease-free survival of patients treated with this regimen.

OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is completed.

Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6, melphalan IV on days -5 and -4, and thiotepa IV on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are treated ex vivo with interleukin-2 (IL-2) on day -1. Patients undergo IL-2-treated autologous PBSC transplantation on day 0.

Beginning 4 hours after PBSC transplantation, patients receive IL-2 IV continuously for 5 days. IL-2 therapy repeats every 7 days for 4 courses.

Patients are followed on days 60-80, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • Washington
      • Seattle, Washington, Forenede Stater, 98109-1024
        • Fred Hutchinson Cancer Research Center

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

Ikke ældre end 56 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of solid tumor, Hodgkin's lymphoma, or B-cell non-Hodgkin's lymphoma
  • Eligible for autologous stem cell transplantation
  • No pleural effusion, pericardial effusion, or ascites
  • No T-cell lymphoma

PATIENT CHARACTERISTICS:

Age:

  • Under 57

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's disease)
  • SGOT or SGPT no greater than 2 times upper limit of normal
  • Hepatitis B and C negative

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • LVEF at least 50%
  • No congestive heart disease
  • No history of myocardial infarction within the past year
  • No coronary artery disease
  • No history of arrhythmia

Pulmonary:

  • Diffusion capacity (corrected) at least 60%
  • FEV_1 at least 65% of predicted

Other:

  • HIV negative
  • No history of seizures
  • No mental disorders requiring medication (e.g., haloperidol)
  • No active connective tissue disease
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or any carcinoma in situ
  • No allergy to gentamicin
  • No hypersensitivity to E. coli-derived preparations
  • No history of severe allergy to sargramostim (GM-CSF) or filgrastim (G-CSF)
  • No systemic infection
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent corticosteroid therapy

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No contrast dye for 3 weeks after completion of interleukin-2 therapy

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
  • Maskning: Ingen (Åben etiket)

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. august 2001

Studieafslutning (Faktiske)

1. november 2007

Datoer for studieregistrering

Først indsendt

7. december 2001

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. maj 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2010

Sidst verificeret

1. maj 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1595.00
  • FHCRC-1595.00
  • IMMUNEX-FHCRC-1595.00
  • NCI-G01-2037
  • CDR0000069095 (Registry Identifier: PDQ)

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 .

Abonner