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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer

25. mars 2011 oppdatert av: NYU Langone Health

Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

  • Determine the maximum tolerated dose of temozolomide in combination with thiotepa and carboplatin followed by autologous peripheral blood stem cell or bone marrow transplantation in patients with recurrent high-grade brain tumors with minimal residual disease or newly-diagnosed malignant glioma with minimal residual disease following irradiation.

OUTLINE: This is a dose-escalation study of temozolomide.

Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 3 consecutive days. After the third dose of G-CSF, patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not have adequate PBSC may undergo bone marrow harvest.

Patients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3.

PBSC or bone marrow are reinfused on day 0. Beginning on day 1, patients receive G-CSF SC or IV until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of temozolomide 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.

Patients are followed at day 42, at 3 months, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.

Studietype

Intervensjonell

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Cancer Institute at New York University Medical Center
    • Ohio
      • Columbus, Ohio, Forente stater, 43205-2696
        • Columbus Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Children's Hospital of Philadelphia

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

1 år til 49 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following malignant brain tumors:

    • Anaplastic astrocytoma
    • Glioblastoma multiforme
    • Anaplastic oligodendroglioma
    • Medulloblastoma
    • High-grade ependymoma
    • Germ cell tumors
    • Pineoblastoma
    • Other primitive neuroectodermal tumors
  • Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy)

    • No prior myeloablative doses of thiotepa OR
  • Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy

    • Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency

PATIENT CHARACTERISTICS:

Age:

  • Over 1 to under 50

Performance status:

  • Karnofsky 70-100% OR
  • Lansky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2.5 times ULN

Renal:

  • Creatinine less than 1.5 times ULN
  • Creatinine clearance at least 70 mL/min
  • BUN less than 1.5 times ULN

Cardiovascular:

  • Ejection fraction greater than 50% OR
  • Shortening fraction greater than 27%
  • No evidence of myocardial ischemia on EKG if over 40 years of age

Other:

  • HIV negative
  • No AIDS-related illness
  • No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction)
  • No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior biologic therapy or immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics
  • At least 6 weeks since prior radiotherapy and recovered
  • At least 6 weeks since prior brachytherapy or radiosurgery

Surgery:

  • See Disease Characteristics
  • Recovered from prior major surgery

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Studiestol: Sharon L. Gardner, MD, NYU Langone Health

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. oktober 2000

Primær fullføring (Faktiske)

1. mai 2007

Datoer for studieregistrering

Først innsendt

11. oktober 2001

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. mars 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mars 2011

Sist bekreftet

1. mars 2011

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. .

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