Neoplasms, GynecologicNCT00038012
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
A study testing Thrombopoietin, Platelet-pheresis and Carboplatin in people with Neoplasms, Gynecologic, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Neoplasms, Gynecologic
- What is being tested?
- Thrombopoietin, Platelet-pheresis and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 1999to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin
- Conditions
- Neoplasms, Gynecologic
- Being tested
- Thrombopoietin, Platelet-pheresis, Carboplatin
- Keywords
- Dose-intensified carboplatin, autologous cryopreserved platelets, thrombopoietin, Gynecologic malignancy
- Medical subject headings
- Genital Neoplasms, Female, Jacobs syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombopoietinDrug
Platelet-pheresisProcedure or surgery
CarboplatinDrug
Also called Paraplatin
| Study group | Role | What they receive |
|---|---|---|
| rhTPO-Derived Autologous Platelets Transfusion | Experimental | Not described Receives: Drug: Thrombopoietin; Procedure: Platelet-pheresis; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: Continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2002 (estimated)
- Study start23 Jul 1999
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, GynecologicStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia, LifeCell
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038012
- Sponsor's protocol ID
- GYN97-310
- Status last verified
- Oct 2018
- First submitted
- 24 May 2002
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin
- ClinicalTrials.gov ID
- NCT00038012
- Acronym / sponsor ID
- GYN97-310
- Conditions
- Neoplasms, Gynecologic
- Keywords
- Dose-intensified carboplatin, autologous cryopreserved platelets, thrombopoietin, Gynecologic malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pharmacia, LifeCell
- Study start
- 23 Jul 1999 (actual)
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 27 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhTPO-Derived Autologous Platelets Transfusion | Experimental | Drug: Thrombopoietin, Procedure: Platelet-pheresis, Drug: Carboplatin |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombopoietin | Drug | rhTPO-Derived Autologous Platelets Transfusion |
| Platelet-pheresis | Procedure or surgery | rhTPO-Derived Autologous Platelets Transfusion |
| CarboplatinAlso: Paraplatin | Drug | rhTPO-Derived Autologous Platelets Transfusion |
Primary outcome
Response Rate
Time frame: Continuous
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombopoietin, Platelet-pheresis and Carboplatin in people with Neoplasms, Gynecologic, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Continuous). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.