NCT00004263

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine. PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Dec 1999

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

7.1 years

First QC Date

January 28, 2000

Last Update Submit

July 27, 2012

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

recurrent adult acute myeloid leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationpreviously treated myelodysplastic syndromeschildhood myelodysplastic syndromesAra-CCytosarDepoCytCytosine arabinosine hydrochloridecytarabine7-hydroxystaurosporineUCN-01

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) Cytarabine + UCN-01

    4 week cycle

Study Arms (1)

Cytarabine + UCN-01

EXPERIMENTAL
Drug: 7-hydroxystaurosporine (UCN-01)Drug: Cytarabine (Ara-C)

Interventions

7-hydroxystaurosporine (UCN-01)DRUG

20 mg/m2 IV over 24 hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses. Treatment repeats every 4 weeks for a maximum of 4 courses.

Cytarabine + UCN-01
Cytarabine (Ara-C)DRUG

Starting dose 1 g/m2 IV over 24 hours on days 1-4 of each course. Treatment repeats every 4 weeks for a maximum of 4 courses.

Also known as: ARA-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride
Cytarabine + UCN-01

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (RAEB or RAEB-T).
  • \. Performance status of =\< 2
  • \. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol for each participating institution.
  • \. Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
  • \. Bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits.
  • \. Patients must have relapsed or failed to respond after high-dose ara-C-based (\>=1g/m2/day x 3 days) chemotherapy.
  • \. Corrected DLCO \>50%.
  • \. Patients with \>=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test.

You may not qualify if:

  • \. The anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. Therefore, pregnant and nursing females will be excluded. Patients of childbearing potential should practice effective methods of contraception.
  • \. Patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant.
  • \. Patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of Blasts

Interventions

7-hydroxystaurosporineCytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidAnemia, RefractoryAnemia

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jorge Cortes, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

July 26, 2004

Study Start

December 1, 1999

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(2)