NCT00038012

Brief Summary

A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

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

July 23, 1999

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

4.9 years

First QC Date

May 24, 2002

Last Update Submit

October 30, 2018

Conditions

Neoplasms, Gynecologic

Keywords

Dose-intensified carboplatinautologous cryopreserved plateletsthrombopoietinGynecologic malignancy

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Continuous

Study Arms (1)

rhTPO-Derived Autologous Platelets Transfusion

EXPERIMENTAL
Drug: ThrombopoietinProcedure: Platelet-pheresisDrug: Carboplatin

Interventions

ThrombopoietinDRUG
rhTPO-Derived Autologous Platelets Transfusion
Platelet-pheresisPROCEDURE
rhTPO-Derived Autologous Platelets Transfusion
CarboplatinDRUG
Also known as: Paraplatin
rhTPO-Derived Autologous Platelets Transfusion

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with gynecologic malignancy for whom treatment with carboplatin is indicated.
  • Age \>/= 15 years.
  • Adequate hematologic, renal, and hepatic functions.
  • Life expectancy \>/- 3 months. Karnofsky Performance Status \>/= 80.
  • Signed informed consent form.

You may not qualify if:

  • Patients with rapidly progressive disease.
  • Pregnant or lactating women.
  • Patients with comorbid condition which renders patients at high risk of treatment complication.
  • History of CNS metastasis.
  • Patients with significant cardiac disease (NYHA Class III or IV), dysrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the 6 months of study entry.
  • Prior chemotherapy, immunotherapy, any experimental drug within 4 weeks, use of myeloid (G-CSF or GM-CSF) growth factors within 2 weeks or erythropoietin within 4 weeks.
  • Use of any nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks.
  • Prior surgery or RT within 2 wks of study entry.
  • Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (\> 2 weeks).
  • History of leukemia.
  • History of any platelet disorders including ITP, TTP or bleeding disorders.
  • History of \> 3 prior chemotherapy regimens (all platinum regimens will be counted as 1 regimen).
  • Demonstrated lack of response to platinum-based therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Genital Neoplasms, FemaleJacobs syndrome

Interventions

ThrombopoietinCarboplatin

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic Chemicals

Study Officials

  • Saroj Vadhan-Raj, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

July 23, 1999

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

US(1)