Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy, such as flavopiridol, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a new schedule of more than one drug (combination chemotherapy) may kill more cancer cells. This phase I trial is studying the side effects, best dose, and best schedule for flavopiridol when given together with cytarabine and mitoxantrone in treating patients with relapsed or refractory acute leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Cytarabine; Mitoxantrone

Criteria

Inclusion Criteria:

• Pathologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia:

• Relapsed >= 1 time OR refractory disease:

• Patients who fail primary induction therapy or who relapse after achieving complete remission are eligible if they have received =< 3 prior courses of induction/reinduction therapy

• Relapsed >= 1 time OR refractory disease

• Patients who fail primary induction therapy or who relapse after achieving complete remission are eligible if they have received =< 3 prior courses of induction/reinduction therapy

• No active CNS leukemia

• ECOG performance status 0-2

• AST and ALT =< 5 times upper limit normal (ULN)

• Alkaline phosphatase =< 5 times ULN

• Bilirubin =< 2.0 mg/dL

• Creatinine =< 2.0 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• LVEF >= 45% by MUGA or ECHO

• No active, uncontrolled infection

• No other life-threatening illness

• No mental deficits and/or psychiatric history that would preclude study compliance

• No active graft-vs-host disease

• Recovered from all prior therapies

• At least 24 hours since prior hydroxyurea, steroids, imatinib mesylate, arsenic trioxide, interferon, or leukapheresis for blast count control

• At least 4 weeks since prior stem cell transplantation (autologous or allogeneic)

• At least 4 days since prior growth factors

• At least 3 weeks since prior chemotherapy, except for non-aplasia producing treatments (e.g., low-dose cyclophosphamide, hydroxyurea, interferon, imatinib mesylate, mercaptopurine, thalidomide, azacitidine, or decitabine)

• No prior flavopiridol

• No other concurrent chemotherapy, radiotherapy, or immunotherapy

• No acute promyelocytic leukemia (M3)

• No hyperleukocytosis with > 50,000 blasts/mm^3