Bortezomib and combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia

eagle-i ID

Resource Type

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1. ClinicalTrials.gov url

   http://www.clinicaltrial.gov/ct2/show/NCT00666588?term=Phase+II+Pilot+Study+of+Bortezomib+and+Reinduction+Chemotherapy+in+Younger+Patients+With+Recurrent%2C+Refractory%2C+or+Secondary+Acute+Myeloid+Leukemia&rank=1

2. Intervention

   Bortezomib

3. Intervention

   Idarubicin/cytarabine

4. Intervention

   Etoposide/cytarabine

5. Additional Topic(s)

   antineoplastic combination chemotherapy

6. Resource Description

   The primary objectives of this study are to determine the toxicities and tolerability of bortezomib in combination with standard-relapse acute myeloid leukemia (AML) therapy (idarubicin/cytarabine or etoposide/high-dose cytarabine) in pediatric and young adult patients with relapsed or primary-refractory or secondary AML, and to estimate the complete response rate to the Arm A and Arm B regimens. This is a multicenter, dose-escalation study of bortezomib. Patients are stratified according to anthracycline-equivalent cumulative exposure (≤ 400 mg/m² vs > 400 mg/m²). Patients are assigned to 1 of 2 groups. Group 1 (efficacy phase, patients with ≤ 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive idarubicin IV over 15 minutes on days 1-3, low-dose cytarabine IV continuously over days 1-7, and bortezomib IV on days 1, 4, and 8. Group 2 (dose-finding phase and efficacy phase, patients with > 400 mg/m² anthracycline-equivalent cumulative exposure): Patients receive etoposide IV over 1 hour on days 1-5, high-dose cytarabine IV over 1 hour twice daily on days 1-5, and bortezomib IV on days 1, 4, and 8. All patients receive intrathecal cytarabine prior to courses 1 and 2. In both arms, treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for at least 5 years.

7. Additional Name

   Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemi

8. Contact

   Berenberg, Jeffrey

9. PI

   Wilkinson, Robert, M.D.

10. Topic

    acute myeloid leukemia

11. Study Population

    90 males and females 1 to 21 years of age.

12. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=660550&version=healthprofessional

13. Funded by

    Children's Oncology Group

14. Phase

    Phase 2 clinical trial

15. Performed by

    Clinical Protocol & Data Management Shared Resource