Gene Therapy Clinical Trials
Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes
This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: asparaginase
- drug: cytarabine
- drug: daunorubicin hydrochloride
- drug: etoposide
- drug: thioguanine
- other: laboratory biomarker analysis
Eligibility
Inclusion Criteria:
- Diagnosis DS or DS mosaicism by karyotype or chromosomal analysis
- Diagnosis of myelodysplastic syndromes (MDS) with < 30% blasts or acute myeloid
leukemia (AML)
- Newly diagnosed disease
- Patients with a history of transient myeloproliferative disorder (TMD) are eligible
provided the patient is diagnosed with AML or MDS at > 90 days of age AND meets either
of the following criteria:
- At least 30% blasts in the bone marrow regardless of time since resolution of TMD
- More than 8 weeks since resolution of TMD with ≥ 5% blasts in the bone marrow
- Immunophenotype required for study entry
- No promyelocytic leukemia
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide
angiogram
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT < 2.5 times ULN
- Creatinine adjusted according to age as follows:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over [female])
- No greater than 1.5 mg/dL (13 years to 15 years [male])
- No greater than 1.7 mg/dL (16 years and over [male])
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- No evidence of dyspnea at rest
- No exercise intolerance
- Pulse oximetry > 94%
- No prior chemotherapy, radiotherapy, or any antileukemic therapy
- Intrathecal cytarabine therapy given at diagnosis allowed
- Prior therapy for TMD allowed
Ages Eligible for Study
N/A - 4 Years
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
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting