Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia

Summary

RATIONALE: Bortezomib and midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and midostaurin together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with midostaurin with or without combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia.

Conditions

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia With Multilineage Dysplasia Following
• Myelodysplastic Syndrome
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Recurrent Adult Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia

Interventions

DRUG

midostaurin

Drug midostaurin, Given orally given twice daily days 1-14

DRUG

Bortezomib

Bortezomib given IV on days 1, 4, 8, and 11

DRUG

mitoxantrone hydrochloride

Patients receive mitoxantrone hydrochloride IV over 10 minutes

DRUG

etoposide

Patients receive etoposide IV over 1 hour

DRUG

cytarabine

Patients receive cytarabine IV over 6 hours on days 1-6

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• Millennium Pharmaceuticals, Inc.

  collaborator INDUSTRY

• Alison Walker

  lead OTHER

Principal Investigators

• Alison Walker, MD · The Ohio State University James Cancer Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2014-04-30

Completion

2016-05-31

Countries

• United States

Study Locations