Trial Search Results

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Arsenic Trioxide
  • Drug: Cytarabine
  • Drug: Dexamethasone
  • Drug: Idarubicin
  • Other: Laboratory Biomarker Analysis
  • Drug: Mitoxantrone Hydrochloride
  • Other: Questionnaire Administration
  • Drug: Tretinoin

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must be newly diagnosed with a clinical diagnosis of APL (initially by
   morphology of bone marrow or peripheral blood)

      - Bone marrow is highly preferred but in cases where marrow cannot be obtained at
      diagnosis, peripheral blood will be accepted

   - If the RQ-PCR results are known at the time of study enrollment, the patient must
   demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible

   - NOTE: A lumbar puncture is not required in order to be enrolled on study nor are
   lumbar punctures recommended at the time of diagnosis; if the diagnosis of APL is
   known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms
   should be deferred until any coagulopathy is corrected; if central nervous system
   (CNS) disease is suspected or proven, a computed tomography (CT) or magnetic resonance
   imaging (MRI) should be considered to rule out the possibility of an associated
   chloroma; if CNS disease is documented, patients are still eligible and will receive
   protocol directed intrathecal treatments

   - Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to
   administration of protocol therapy

   - Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine
   prior to beginning protocol directed therapy is allowed; however, it should be noted
   that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not
   recommended

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients with secondary APL are excluded; this includes all patients with APL that may
   have resulted from prior treatment (chemotherapy or radiation)

   - Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia
   cutis) but without evidence of APL by bone marrow or peripheral blood morphology are
   excluded

   - Patients with a pre-existing diagnosis of a prolonged QT syndrome (even if corrected
   QT interval [QTc] is normal at the time of APL diagnosis) are excluded

   - Patients with a baseline QTc of > 450 msec are excluded; Bazett's formula is to be
   used for measurement of the corrected QT interval: the QT interval (msec) divided by
   the square root of the RR interval (msec)

   - Patients with a history or presence of significant ventricular or atrial
   tachyarrhythmia are excluded

   - Patients with right bundle branch block plus left anterior hemiblock, bifascicular
   block are excluded

   - Patients with serum creatinine > 3.0 mg/dL and patients on active dialysis for renal
   dysfunction are excluded

   - Patients who have received treatment with any other cytotoxic chemotherapy prior to
   beginning protocol therapy (other than allowed in above criteria) are excluded

   - Female patients who are pregnant are exclude; patients should not be pregnant or plan
   to become pregnant while on treatment; a pregnancy test prior to enrollment is
   required for female patients of childbearing potential

   - Lactating females who plan to breastfeed their infants are excluded

   - Sexually active patients of reproductive potential who have not agreed to be abstinent
   or use 2 forms of effective contraception during treatment through 1 month off therapy
   are excluded

Ages Eligible for Study

1 Year - 21 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christina Baggott
650-497-7659
Recruiting