Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama Comprehensive Cancer Center
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, Förenta staterna, 92093-0658
- University of California San Diego Cancer Center
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Palo Alto, California, Förenta staterna, 94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Miami, Florida, Förenta staterna, 33136
- Sylvester Cancer Center, University of Miami
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Förenta staterna, 60614
- Children's Memorial Hospital, Chicago
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160-7357
- University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02111
- Floating Hospital for Children
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Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Children's Hospital of Michigan
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Förenta staterna, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, Förenta staterna, 14263-0001
- Roswell Park Cancer Institute
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Syracuse, New York, Förenta staterna, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38105-2794
- Saint Jude Children's Research Hospital
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Texas
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Dallas, Texas, Förenta staterna, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, Förenta staterna, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine
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San Antonio, Texas, Förenta staterna, 78284
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Midwest Children's Cancer Center
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Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, Kanada, H3T 1C5
- Hôpital Sainte Justine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Arm I
See arm description.
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Victor Aquino, MD, Simmons Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (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
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCI-2012-01837
- POG-9675
- CDR0000066219 (Registeridentifierare: PDQ (Physician Data Query))
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