- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00014573
Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Biologisk: aldesleukin
- Läkemedel: cyklofosfamid
- Läkemedel: cisplatin
- Procedur: konventionell kirurgi
- Procedur: stamcellstransplantation av perifert blod
- Läkemedel: paklitaxel
- Biologisk: filgrastim
- Procedur: autolog benmärgstransplantation
- Biologisk: sargramostim
- Läkemedel: karmustin
- Biologisk: terapeutiska autologa lymfocyter
- Biologisk: autologt tumörcellsvaccin
Detaljerad beskrivning
OBJECTIVES:
- Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow or peripheral blood stem cell transplantation, and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors.
- Determine the safety and toxicity of this regimen in these patients.
- Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen.
OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until peripheral blood stem cell (PBSC) or bone marrow collection is completed.
After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after the last vaccination, patients undergo a second leukapheresis to collect lymphocytes.
After completion of the second leukapheresis, patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1 hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every other day for 10 days.
Patients are followed at 18, 24, 36, 40, and 52 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed active recurrent or refractory primary high-grade brain tumor
- Tumor must be surgically accessible
Bidimensionally measurable disease by clinical exam, CT scan, or x-ray
- Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy
- Previously treated metastatic bony lesions are not considered measurable
- No previously irradiated metastatic disease site unless no response or clear progression on imaging
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- CALGB 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Liver function less than 2.5 times normal unless due to disease
- No active hepatitis B or C
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram
- Electrocardiogram normal
Pulmonary:
- FEV1 and DLCO greater than 50% predicted OR
- Clearance by pulmonologist
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study
- Able to be weaned off steroids after surgery
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Recovered from prior conventional chemotherapy
Endocrine therapy:
- No concurrent steroid therapy for mass effect
Radiotherapy:
- See Disease Characteristics
- Recovered from prior conventional radiotherapy
Surgery:
- See Disease Characteristics
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Esteban Abella, MD, Barbara Ann Karmanos Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- höggradigt cerebralt astrocytom i barndomen
- vuxen glioblastom
- vuxen jättecellsglioblastom
- vuxen gliosarkom
- återkommande vuxen hjärntumör
- anaplastiskt astrocytom hos vuxna
- vuxen anaplastisk ependymom
- vuxen hjärnstamgliom
- vuxen könscellstumör i centrala nervsystemet
- vuxen choroid plexus tumör
- vuxen ependymoblastom
- vuxen medulloblastom
- vuxen grad III meningiom
- vuxen blandad gliom
- barndomens infratentoriella ependymom
- supratentoriellt ependymom i barndomen
- återkommande supratentoriell primitiv neuroektodermal tumör i barndomen
- återkommande cerebralt astrocytom i barndomen
- återkommande barndomsependymom
- återkommande hjärnstamgliom i barndomen
- återkommande medulloblastom i barndomen
- barndomens centrala nervsystemets könscellstumör
- barndoms choroid plexus tumör
- meningiom i barndomsgrad III
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Anti-HIV-medel
- Antiretrovirala medel
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Aldesleukin
- Cyklofosfamid
- Paklitaxel
- Karmustin
- Sargramostim
Andra studie-ID-nummer
- CDR0000068559
- P30CA022453 (U.S.S. NIH-anslag/kontrakt)
- WSU-D-1654
- WSU-07-92-98-P04-FB (Annan identifierare: Wayne State University - Human Investigation Committee)
- NCI-G01-1937
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