NCT00283582

Brief Summary

Intensive chemotherapy is often associated with low platelet counts often requiring platelet transfusions to maintain platelet counts. In previous clinical studies administration of rhTPO has been demonstrated to increase platelet counts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

June 1, 2001

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

3.4 years

First QC Date

January 27, 2006

Last Update Submit

October 29, 2018

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

  • CBC with diff. at least three times a week and daily if platelet less than 50,000. Chemistry, coagulation, urinalysis performed at baseline and at end of cycle if necessary.

Interventions

rhTPODRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed new diagnosis of moderate or high-grade sarcoma (except leiomyosarcoma of gastrointestinal origin)
  • Must have high risk disease by American Joint Committee on Cancer (AJCC) Staging System Stage IIC, III, or IV
  • Must have recovered from surgery for a minimum of 2 weeks
  • Must be scheduled for a minimum of 4 cycles of AI therapy
  • Must be 13 years or older
  • Must have ECOG performance status of 0, 1, or 2.
  • Must have life expectancy of at least 12 weeks.
  • Left ventricular ejection fraction must be more than 50%.
  • Laboratory data within normal limits.

You may not qualify if:

  • Prior front-line standard or experimental therapy for sarcoma
  • History of bone marrow and or peripheral blood progenitor cell transplantation
  • Prior pelvic radiation or radiation therapy to more than 25% of bone marrow reserves
  • Prior treatment with megakaryocyte growth and differentiation factor
  • Prior treatment with rhTPO
  • History of platelet disorder
  • History of myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis within the past 12 months
  • Pregnant or lactating women
  • Use of anticoagulants such as coumadin, heparin, etc.
  • Known HIV or hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Saroj Vadhan-Raj, M.D.

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

June 1, 2001

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

US(1)