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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 November 2012 |
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Main ID: |
NCT00462787 |
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Date of registration:
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18/04/2007 |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia
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Scientific title:
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A Phase I Dose Escalation Trial of Clofarabine in Addition to Topotecan, Vinorelbine, Thiotepa, and Dexamethasone in Pediatric Patients With Relapsed or Refractory Acute Leukemia |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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23 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00462787 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Neerav Shukla, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Memorial Sloan-Kettering Cancer Center |
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Name:
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Peter G. Steinherz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Memorial Sloan-Kettering Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Must have 1 of the following diagnoses:
- Acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:
- Refractory to initial induction with two or more standard regimens
- Relapsed < 24 months after first complete response on a high-risk protocol
OR refractory to one standard reinduction regimen
- Second or greater relapse
- Acute myeloid leukemia, acute biphenotypic leukemia, or acute undifferentiated
leukemia meeting 1 of the following criteria:
- Refractory to initial induction
- First or greater relapse
- Must have > 20% bone marrow blasts, or evidence of recurrent disease at an
extramedullary site
- No symptomatic CNS disease
- Patients with asymptomatic CNS disease are eligible with the approval of the
principal investigator
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 70-100% OR Lansky PS 70-100%
- AST and ALT < 4 times upper limit of normal
- Bilirubin < 2.0 mg/dL (unless liver involvement)
- Creatinine within normal range for age OR creatinine clearance > 60 mL/min/1.73 m^2
- Adequate cardiac function (either asymptomatic with no prior risk factors, or if
symptomatic, left ventricular ejection fraction > 50% at rest)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled viral, bacterial, or fungal infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior clofarabine
- More than 2 weeks since prior systemic chemotherapy
- At least 7 days since prior chemotherapy for patients with rapidly progressive
disease and recovered
Age minimum:
N/A
Age maximum:
28 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leukemia
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Intervention(s)
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Biological: filgrastim
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Drug: clofarabine
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Drug: dexamethasone
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Drug: thiotepa
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Drug: topotecan hydrochloride
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Drug: vinorelbine tartrate
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Primary Outcome(s)
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Maximum tolerated dose of clofarabine
[Time Frame: 2 years]
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Overall survival
[Time Frame: 2 years]
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Progression-free survival
[Time Frame: 2 years]
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Secondary ID(s)
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07-012
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MSKCC-07012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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