Gene Therapy Clinical Trials
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals:
PRIMARY OBJECTIVE:
- Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL.
SECONDARY OBJECTIVES:
- Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.
- Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.
- Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cytarabine
- drug: Etoposide
- drug: Vincristine
- drug: ITMHA
- drug: Dexamethasone
- drug: Mitoxantrone
- drug: Pegaspargase
- drug: Asparaginase Erwinia Chrysanthemi
- drug: Bortezomib
- drug: Vorinostat
- drug: Cyclophosphamide
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Leucovorin Calcium
Eligibility
Inclusion Criteria:
- Patient is ≤ 365 days of age at the time of diagnosis.
- Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute
undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without
extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage
or biphenotypic acute leukemia are eligible, provided the morphology and
immunophenotype are predominantly lymphoid.
- Limited prior therapy, including hydroxyurea for 72 hours or less, systemic
glucocorticoids for one week or less, one dose of vincristine, and one dose of
intrathecal chemotherapy.
- Written informed consent following Institutional Review Board, NCI, FDA, and Office
for Human Research Protections (OHRP) Guidelines.
Exclusion Criteria:
- Patients with prior therapy, other than therapy specified in the Inclusion Criteria.
- Patients with mature B-cell ALL or acute myelogenous (AML).
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian/representative to give written informed
consent.
Ages Eligible for Study
N/A - 365 Days
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting