Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.

Eligibility Criteria

Inclusion Criteria

PRIOR CONCURRENT THERAPY: No more than 1 prior treatment No prior salvage therapy No prior mitoxantron

DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome in one of the following categories: In first relapse Failed to achieve initial complete remission Newly diagnosed secondary AML eligible Required bone marrow status: Greater than 25% blasts (M3) OR Persistent abnormal clone on cytogenetics and 5-25% blasts (M2) No Fanconi's anemia

PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times normal AST or ALT less than 4.0 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR greater than 70 mL/min per 1.73 square meters or GFR in equivalent institutional normal range Cardiovascular: Shortening fraction greater than 27% by echocardiogram or in institutional normal range OR Ejection fraction greater than 47% by radionuclide angiogram

Treatment Details

Interventions

Allogeneic Bone Marrow Transplantation (N/A)
Autologous Bone Marrow Transplantation (N/A)
Cladribine (Alkylating agents)
Etoposide (Topoisomerase Inhibitor)
Filgrastim (Cytokine)
Low-LET Cobalt-60 Gamma Ray Therapy (N/A)
Low-LET Electron Therapy (N/A)
Low-LET Photon Therapy (N/A)
Methotrexate (Anti-metabolites)
Mitoxantrone Hydrochloride (Anti-tumor antibiotic)
Peripheral Blood Stem Cell Transplantation (N/A)
Therapeutic Hydrocortisone (Corticosteroid)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment13 Interventions

Induction will consist of one course of cytarabine and mitoxantrone. Patients achieving a complete or partial response by the end of induction will start intensification. Intensification will consist of one course of chemotherapy (Cytarabine (Ara-C), Etoposide (VP-16), Filgrastim (G-CSF)). Patients who do not attain a CNS remission following the completion of intensification therapy, or who develop recurrence of CNS disease and have not previously received radiation therapy involving the central nervous system should receive craniospinal radiotherapy. Continuation Therapy: cladribine (2CdA), Etoposide.

Cladribine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Leustatin for: