Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND #58,443) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrial.gov/ct2/show/NCT00873093

2. Intervention

   Filgrastim

3. Intervention

   Asparaginase

4. Intervention

   Bortezomib

5. Intervention

   Cyclophosphamide

6. Intervention

   Cytarabine

7. Intervention

   Doxorubicin hydrochloride

8. Intervention

   Etoposide phosphate

9. Intervention

   Leucovorin calcium

10. Intervention

    Methotrexate

11. Intervention

    Pegaspargase

12. Intervention

    Prednisone

13. Intervention

    Therapeutic hydrocortisone

14. Intervention

    Vincristine sulfate

15. Resource Description

    "This phase II trial is studying the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma."

16. Additional Name

    Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

17. Contact

    Berenberg, Jeffrey

18. PI

    Wilkinson, Robert, M.D.

19. Topic

    lymphoblastic leukemia

20. Study Population

    Males and females aged 1-31 years old without optic nerve or retina involvement, Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndrome, no previous bortezomib, and at least 2 weeks since cytotoxic therapy and at least 4 months since stem cell transplant.

21. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=638413&version=healthprofessional

22. Funded by

    Children's Oncology Group

23. Phase

    Phase 2 clinical trial

24. Performed by

    Clinical Protocol & Data Management Shared Resource