Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES: I. Determine the feasibility and toxicity of timed sequential remission induction and consolidation in children with newly diagnosed acute myeloid leukemia. II. Determine the feasibility and toxicity of a single high dose of melphalan with peripheral blood stem cell rescue following an intense timed sequential induction and consolidation in these children.
OUTLINE: This is a multicenter study. Remission induction: Patients receive daunorubicin IV over 15 minutes on days 1-3, cytarabine IV continuously on days 1-7, oral thioguanine daily on days 1-7, and cytarabine intrathecally (IT) on day 1. Cytarabine IV over 3 hours is administered every 12 hours on days 10-12. Filgrastim (G-CSF) is administered IV or subcutaneously (SQ) beginning on day 13 and continuing until blood counts recover. On approximately day 28, patients undergo a bone marrow aspirate and biopsy to assess response. Patients who have attained an M1 or M2a status proceed to consolidation or, if a 5/5 or 6/6 HLA matched sibling donor is available, proceed to allogeneic bone marrow transplantation. Patients with greater than 25% blasts go off study. Consolidation 1: Patients receive daunorubicin IV over 15 minutes on days 1 and 2, cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, and asparaginase on days 2 and 9. G-CSF IV or SQ begins on day 10 and continues until blood counts recover. Consolidation 2: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. G-CSF IV or SQ begins on day 6 and continues until blood counts recover. Peripheral blood stem cells (PBSC) are collected after the second course of consolidation. Consolidation 3: Treatment is repeated as in consolidation 1. Patients who remain in morphologic remission after consolidation 3 proceed with therapy. Patients receive melphalan IV over 30 minutes on day -2, then PBSC are reinfused on day 0. G-CSF IV or SQ begins on day 1 and continues until blood counts recover. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 8 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
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California
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford
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San Diego, California, Forente stater, 92123-4282
- Children's Hospital and Health Center
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Florida
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Jacksonville, Florida, Forente stater, 32207
- Nemours Children's Clinic
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital, Chicago
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Maine
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Scarborough, Maine, Forente stater, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forente stater, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
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Missouri
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Saint Louis, Missouri, Forente stater, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
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Hackensack, New Jersey, Forente stater, 07601
- Tomorrows Children's Institute
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New York
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New York, New York, Forente stater, 10029
- Mount Sinai School of Medicine
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Texas
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Dallas, Texas, Forente stater, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, Forente stater, 76104
- Cook Children's Medical Center - Fort Worth
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Midwest Children's Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Histologically proven, previously untreated primary acute myeloid leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down syndrome
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram Pulmonary: No uncontrolled, life threatening pneumonia Other: No uncontrolled, life threatening sepsis or meningitis Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Chemo + STEM cell
See detailed description.
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Andre navn:
Andre navn:
Andre navn:
Andre navn:
Andre navn:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy
Tidsramme: Length of study
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To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML.
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Length of study
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Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue
Tidsramme: Length of study
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To test the feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue following an intense timed-sequential induction and consolidation.
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Length of study
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Make observations regarding PCR evidence of Minimal Residual Disease
Tidsramme: Length of study
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To make observations regarding PCR evidence of Minimal Residual Disease in patients with relevant specific translocations who obtain a clinical remission.
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Length of study
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Craig A. Hurwitz, MD, Maine Children's Cancer Program at Barbara Bush Children's Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Hurwitz CA, Chang M, Graham M, et al.: Timed-sequential remission induction and intensification followed by stem cell rescue for childhood AML -a POG pilot study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1553, 2002.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- akutt erytroleukemi i barndommen (M6)
- akutt megakaryocytisk leukemi i barndommen (M7)
- akutt minimalt differensiert myeloid leukemi (M0) i barndommen
- ubehandlet akutt myeloid leukemi hos barn og andre myeloide maligniteter
- akutt myeloblastisk leukemi i barndommen uten modning (M1)
- akutt myeloblastisk leukemi i barndommen med modning (M2)
- akutt myelomonocytisk leukemi i barndommen (M4)
- akutt monoblastisk leukemi hos barn og akutt monocytisk leukemi (M5)
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Leukemi
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Adjuvanser, immunologiske
- Antibiotika, antineoplastisk
- Lenograstim
- Melphalan
- Cytarabin
- Daunorubicin
- Asparaginase
- Tioguanin
Andre studie-ID-numre
- 9822
- POG-9822
- CDR0000067253
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