Phase II Study of Subcutaneous Bortezomib in Combination With Chemotherapy in Relapsed/Refractory Adult Acute Lymphoblastic Leukemia

This phase II trial studies how well giving bortezomib together with combination chemotherapy works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Stanford is now accepting new patients for this trial. Please contact Ying Hao, PhD at 650-723-0646 for more information.

Investigator(s):

Intervention(s):

  • drug : bortezomib
  • drug : doxorubicin hydrochloride
  • drug : pegaspargase
  • drug : methotrexate
  • drug : dexamethasone
  • drug : cytarabine
  • drug : vincristine sulfate

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care - Female subjects who: - Are postmenopausal for at least 1 year before the screening visit, OR - Are surgically sterile, OR - If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse - Male subjects, even if surgically sterilized (i.e., status post vasectomy) who: - Agree to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, OR - Agree to completely abstain from heterosexual intercourse - ? The patient has relapsed or refractory B or T cell acute lymphoblastic leukemia that has progressed following at least one prior therapy. Ph+ patients are eligible. Relapsed ALL is defined in patients as the reappearance of leukemia cells in the peripheral blood or bone marrow or appearance of extramedullary disease after a complete remission. Refractory ALL is defined in patients as failure to achieve a complete remission after induction therapy. Complete remission is defined by <5% leukemia cells in the bone marrow with recovery of peripheral blood counts. Relapsed disease can be documented by bone marrow biopsy (>5% cells in the bone marrow) or by flow cytometry in the peripheral blood or biopsy of extramedullary disease. - Must have received at least one (1) line of prior systemic therapy that may NOT have included VELCADE (bortezomib); patients who have undergone autologous/allogeneic stem cell transplantation are eligible - Transplant eligible patients are eligible - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, or psychiatric illness that in the opinion of the investigator would limit compliance with study requirements - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal - Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is deemed due to leukemia infiltration. In these patients, dose modifications may be required based on standard guidelines. - Patients must have adequate renal function defined as creatinine clearance of >= 30 ml/minute (Cockcroft-Gault)

External Links

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Contact information

Primary Contact:

Ying Hao, PhD 650-723-0646

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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