Overview

Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Aldesleukin
Busulfan
Cytarabine
Daunorubicin
Etoposide
Etoposide phosphate
Interleukin-2
Criteria
Inclusion Criteria:

- Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the
World Health Organization [WHO] and/or French-American-British Cooperative group [FAB]
classifications), excluding M3 (acute promyelocytic leukemia); patients with
antecedent myelodysplasia are eligible for treatment on this trial only if there was
no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to
enrollment; patients with therapy-related MDS or therapy-related AML or a chronic
myeloproliferative disorder are not eligible

- No prior treatment for leukemia or myelodysplasia with four permissible exceptions:

- Emergency leukapheresis

- Emergency treatment for hyperleukocytosis with hydroxyurea

- Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one
dose only)

- Growth factor/cytokine support