Trial Search Results

Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed Acute Leukemia

Phase I trial to study the effectiveness of PSC-833 plus etoposide and mitoxantrone in treating children who have refractory or relapsed acute leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining PSC-833 with chemotherapy may reduce resistance to the drug and allow more cancer cells to be killed.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: etoposide
  • Drug: mitoxantrone hydrochloride
  • Drug: valspodar

Phase:

Phase 1

Eligibility


DISEASE CHARACTERISTICS:

   - Acute myeloid leukemia (AML) in one of the following categories:

   - First relapse if initial CR less than 6 months

   - Refractory to first or second induction with daunomycin, cytarabine, and thioguanine
   (DAT) or other anthracycline-containing regimens

   - Relapse following bone marrow transplantation provided good trilineage engraftment
   followed transplant and greater than 6 months since transplant

   - Presentation with secondary AML or AML evolving from myelodysplastic syndrome --Acute
   lymphocytic leukemia in one of the following categories:

   - In second or subsequent relapse or failed second or later induction attempts
   regardless of prior remissions

   - Relapsed following bone marrow transplantation provided good trilineage engraftment
   followed transplant and greater than 6 months since transplant

   - No isolated CNS or extramedullary relapse

PATIENT CHARACTERISTICS:

   - Age: Under 22 at diagnosis

   - Performance status: Karnofsky 50-100% (ECOG 0-2)

   - Lansky 40-100% (in patients under 12 years of age)

   - Life expectancy: At least 8 weeks

   - Bilirubin less than 1.5 mg/dL

   - ALT less than twice normal

   - Creatinine normal for age (within 2 standard deviations) OR glomular filtration rate
   at least 70 mL/min

   - Albumin at least 3 g/dL

   - Ejection fraction greater than 50% at rest or with 5% increase with exercise OR
   shortening fraction greater than 27% by echocardiogram

   - No history of clinical heart failure

   - No uncontrolled infection

   - No anticonvulsant therapy

   - No history of allergic reactions or anaphylaxis to etoposide not remediable by
   premedication

   - Not pregnant or nursing

   - Fertile patients must use effective contraception

   - Third percentile weight for height

PRIOR CONCURRENT THERAPY:

   - At least 4 weeks since chemotherapy and recovered

   - Prior cumulative anthracycline dose no greater than 360 mg per square meter

   - Hydroxyurea therapy allowed just prior to study for rapidly rising blast count

Ages Eligible for Study

N/A - 21 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
Not Recruiting