Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
I. Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors.
II. Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients.
III. Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications.
IV. Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide.
V. Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide.
OUTLINE: This is a dose escalation study.
Patients receive tirapazamine by 2 hour intravenous infusion (hours 0-2) followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide. This course is repeated every 3 weeks in patients with partial/complete response or stable disease for a maximum of 1 year. Cohorts of 3-6 patients each are treated at each dose level of tirapazamine. Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity (DLT). If DLT is experienced in 1 of 3 patients at a given dose level, up to 3 additional patients are treated at that same dose level. If none of the 3 additional patients at that dose level experiences DLT, the dose is escalated. If DLT is experienced in 1 or more of the additional 3 patients, the maximum tolerated dose (MTD) has been exceeded and 3 patients are treated at the next lower dose level (defined as the MTD). A total of six patients are treated at the MTD. If DLT is proved to be neutropenia, patients must then also meet the additional eligibility criteria listed for stratum 2. If neutropenia continues to be the DLT in stratum 2, then additional patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning 24 hours after cyclophosphamide. A second MTD may be determined for chemotherapy with G-CSF. Patients are followed every 6 months for 4 years, and then annually thereafter.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University Of Alabama Comprehensive Cancer Center
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, Stati Uniti, 92093-0658
- University of California San Diego Cancer Center
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Palo Alto, California, Stati Uniti, 94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Miami, Florida, Stati Uniti, 33136
- Sylvester Cancer Center, University of Miami
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Stati Uniti, 60614
- Children's Memorial Hospital, Chicago
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160-7357
- University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02111
- Floating Hospital for Children
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Michigan
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Detroit, Michigan, Stati Uniti, 48201
- Children's Hospital of Michigan
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Stati Uniti, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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Syracuse, New York, Stati Uniti, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38105-2794
- Saint Jude Children's Research Hospital
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Texas
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Dallas, Texas, Stati Uniti, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, Stati Uniti, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
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San Antonio, Texas, Stati Uniti, 78284
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Midwest Children's Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor that is refractory to conventional therapy or for which no effective therapy is known
- Brain tumors eligible Brainstem gliomas may waive histological verification requirement
- Neurologic deficits associated with CNS malignancies must be stable for a minimum of 4 weeks prior to study
- No leukemia Stratum 2
- No marrow involvement
PATIENT CHARACTERISTICS:
- Age: 21 and under
- Performance status: Karnofsky or Lansky 50-100%
- Life expectancy: At least 8 weeks
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 75,000/mm3
- Hemoglobin at least 9 g/dL
- Bilirubin less than 1.5 mg/dL
- SGPT less than 5 times normal
- Creatinine normal for age OR creatinine clearance at least 70 mL/min
- Shortening fraction at least 27% of normal OR ejection fraction greater than 50% of normal
- Not pregnant or nursing
- Negative pregnancy test required
PRIOR CONCURRENT THERAPY:
- No concurrent anticancer therapy
- At least 6 months since bone marrow transplant and no evidence of graft versus host disease
- At least 1 week since growth factors
- No concurrent granulocyte colony-stimulating factor
- Recovered from prior immunotherapy
- Stratum 2: No prior bone marrow transplantation (with or without total body irradiation)
- At least 6 weeks since prior nitrosourea
- At least 2 weeks since other prior myelosuppressive chemotherapy
- Dexamethasone must be a stable or decreasing dose for 2 weeks prior to study
- Recovered from prior chemotherapy
- Stratum 2: No more than 2 prior chemotherapy regimens
- At least 2 weeks since local palliative radiotherapy (small port)
- At least 6 months since prior substantial bone marrow radiation (e.g., cross- sectional radiotherapy [greater than 24 Gy], total body irradiation, hemi- pelvic radiotherapy)
- Recovered from prior radiotherapy
- Stratum 2: No prior central axis radiation
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)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Arm I
See arm description.
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Victor Aquino, MD, Simmons Cancer Center
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Inizio studio
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Date di iscrizione allo studio
Primo inviato
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Primo Inserito (Stima)
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCI-2012-01837
- POG-9675
- CDR0000066219 (Identificatore di registro: PDQ (Physician Data Query))
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