- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00060255
High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
- Procedura: trapianto di cellule staminali del sangue periferico
- Droga: busulfan
- Droga: carboplatin
- Droga: carmustine
- Droga: cyclophosphamide
- Droga: etoposide
- Droga: melphalan
- Droga: thiotepa
- Procedura: autologous bone marrow transplantation
- Procedura: bone marrow ablation with stem cell support
- Radiazione: radiation therapy
Descrizione dettagliata
OBJECTIVES:
- Determine the morbidity, mortality, and overall outcome in patients with hematologic malignancies, breast cancer, or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation.
OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk includes acute leukemia in first relapse or second remission; lymphoma in responding first relapse or second remission; or breast cancer at risk for recurrence. High risk includes all others. Patients receive specific conditioning regimens according to diagnosis as outlined below.
Conditioning
- Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide, cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4. Patients undergo TBI on days -3 to -1.
- Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide, carmustine, and etoposide (CBV): Patients receive etoposide IV continuously over 34 hours beginning on day -8; cyclophosphamide IV over 2 hours on days -7 to -4; and carmustine IV over 2 hours on day -3.
- Regimen C (any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
- Regimen D (multiple myeloma or amyloidosis)-Melphalan only (MEL only): Patients receive melphalan IV over 30 minutes on day -2.
- Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
- Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
- Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6.
- Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4.
Stem Cell Infusion
- In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen) will be accrued for this study within 10 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
New York
-
Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic or solid tumor malignancy, including any of the following:
Acute myeloid leukemia
- First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission
- Not eligible for protocol CLB-9620 or CLB-9621
Acute lymphoblastic leukemia
- First complete remission without appropriate allogeneic donor
Chronic myelogenous leukemia
- Chronic, accelerated, or blast phase
Lymphoproliferative diseases*
- Chronic lymphocytic leukemia
- Multiple myeloma
- Waldenstrom's macroglobulinemia
- Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently
Amyloidosis
- Primary or previously treated disease
NHL (intermediate- and high-grade)
- Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse
- CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L
Hodgkin's lymphoma
- Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
Solid tumors
- High-risk and metastatic breast cancer
- Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy
- Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity
- Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged)
Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:
- Over 60 years of age
- No compatible donor identified
- Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation
- Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens
Hormone receptor status:
- Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 4 and over (patients 60 years of age and over are not eligible for TBI)
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 2 months
Hematopoietic
- WBC greater than 3,000/mm^3*
- Polymorphonuclear leukocyte count greater than 1,500/mm^3*
- Platelet count greater than 75,000/mm^3*
- Marrow cellularity greater than 20%*
- No marrow fibrosis* NOTE: *Before marrow storage
Hepatic
- Bilirubin less than 3 times normal
- Alkaline phosphatase less than 3 times normal
- AST less than 3 times normal
- Hepatitis status known
Renal
- Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma)
Cardiovascular
- Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No symptomatic angina
- No life-threatening arrhythmia or hypertension
Pulmonary
- DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation)
Other
- Not pregnant
- HIV negative
- Cytomegalovirus status known
- No active bacterial, viral, or fungal infection
- No active peptic ulcer disease
- No uncontrolled diabetes mellitus
- No serious organ dysfunction unless it is caused by the underlying disease
- No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
- No prior cumulative nitrosourea dose greater than 600 mg/m^2
- No prior cumulative bleomycin dose greater than 150 units/m^2
- No prior cumulative doxorubicin dose greater than 450 mg/m^2
- No prior cumulative daunorubicin dose greater than 600 mg/m^2
- Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy (before blood stem cell harvest)
Prior cumulative doses of radiotherapy must not exceed the following:
- Spine/spinal cord: 4,000 cGy
- Mediastinum: 4,000 cGy
- Heart: 4,000 cGy
- Kidney (whole): 1,500 cGy
- Small bowel: 4,000 cGy
- Brain: 4,000 cGy
- Liver (whole): 2,000 cGy
- Lungs (whole): 1,500 cGy
- Bone: 5,000 cGy
Surgery
- Not specified
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Morbidity
Lasso di tempo: +day 100
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+day 100
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Mortality
Lasso di tempo: +day 100, +day 360
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+day 100, +day 360
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Overall outcome
Lasso di tempo: every 6 months until death
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every 6 months until death
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Response rate
Lasso di tempo: +day 100, +day 360
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+day 100, +day 360
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Toxicity
Lasso di tempo: +day100, +day 360
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+day100, +day 360
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Disease-free survival
Lasso di tempo: up to 15years
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up to 15years
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Overall survival
Lasso di tempo: every 6 months until death
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every 6 months until death
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Philip L. McCarthy, MD, Roswell Park Cancer Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- tumore solido infantile non specificato, protocollo specifico
- carcinoma mammario in stadio IV
- carcinoma mammario in stadio IIIA
- carcinoma mammario ricorrente
- carcinoma mammario in stadio IIIB
- tumore solido adulto non specificato, protocollo specifico
- cancro al seno maschile
- carcinoma mammario in stadio IIIC
- linfoma follicolare ricorrente di grado 3
- linfoma diffuso a grandi cellule dell'adulto ricorrente
- linfoma immunoblastico a grandi cellule dell'adulto ricorrente
- linfoma di Burkitt ricorrente dell'adulto
- linfoma a piccole cellule non clivate ricorrente nell'infanzia
- linfoma infantile ricorrente a grandi cellule
- leucemia mieloide acuta dell'adulto con anomalie 11q23 (MLL).
- leucemia mieloide acuta dell'adulto con inv(16)(p13;q22)
- leucemia mieloide acuta dell'adulto con t(15;17)(q22;q12)
- leucemia mieloide acuta dell'adulto con t(16;16)(p13;q22)
- leucemia mieloide acuta dell'adulto con t(8;21)(q22;q22)
- leucemia linfoblastica acuta infantile in remissione
- leucemia mieloide acuta infantile in remissione
- leucemia mieloide cronica in fase cronica
- leucemia mieloide cronica infantile
- amiloidosi sistemica primaria
- leucemia mieloide acuta ricorrente dell'adulto
- leucemia mieloide cronica atipica
- leucemia mieloide acuta dell'adulto in remissione
- linfoma di Hodgkin ricorrente dell'adulto
- linfoma di Hodgkin infantile ricorrente/refrattario
- linfoma diffuso a piccole cellule recidivante dell'adulto
- linfoma diffuso a cellule miste ricorrente dell'adulto
- leucemia mieloide cronica in fase blastica
- Macroglobulinemia di Waldenstrom
- linfoma follicolare ricorrente di grado 1
- linfoma follicolare ricorrente di grado 2
- linfoma ricorrente della zona marginale
- piccolo linfoma linfocitico ricorrente
- linfoma a cellule B della zona marginale extranodale del tessuto linfoide associato alla mucosa
- linfoma a cellule B della zona marginale nodale
- linfoma splenico della zona marginale
- linfoma mantellare ricorrente
- leucemia linfatica cronica refrattaria
- mieloma multiplo refrattario
- leucemia mieloide cronica in fase accelerata
- leucemia linfoblastica acuta dell'adulto in remissione
- leucemia mieloide acuta infantile ricorrente
- linfoma linfoblastico infantile ricorrente
- Tumore a cellule germinali testicolare maligno ricorrente
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie della pelle
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Neoplasie per sede
- Malattie ematologiche
- Malattie del seno
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Neoplasie
- Linfoma
- Neoplasie, cellule germinali ed embrionali
- Neoplasie mammarie
- Mieloma multiplo
- Neoplasie, plasmacellule
- Leucemia
- Plasmocitoma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antireumatici
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Ciclofosfamide
- Carboplatino
- Etoposide
- Melfalan
- Thiotepa
- Busulfano
- Carmustina
Altri numeri di identificazione dello studio
- CDR0000301587
- RPCI-DS-9115
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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