Overview

A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

Status:
Terminated

Trial end date:
2013-04-01

Target enrollment:

Participant gender:

Summary

1.1 Primary Objectives - To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease - To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts - To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone - To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS 1.2 Secondary Objectives: - To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo - To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity

Phase:

Phase 1

Details

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators:

Pfizer
The Leukemia and Lymphoma Society

Treatments:

Cytarabine
Mitoxantrone
Palbociclib