Brain and Central Nervous System TumorsPhase 2NCT00070096
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
A Phase 2 study testing ixabepilone in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer
- What is being tested?
- ixabepilone
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jun 2007
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:
- Measurable metastatic disease by one of the following methods:
- Radiography
- If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
- Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
- Previously treated progressive disease meeting 1 of the following criteria:
- Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
- Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
- Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT)
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.2 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- No other concurrent cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent experimental or commercial anticancer medications or therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
- Determine the safety of this drug in these patients.
OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
- Being tested
- ixabepilone
- Keywords
- stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, adult central nervous system germ cell tumor, recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor
- Medical subject headings
- Central Nervous System Neoplasms, Ovarian Neoplasms, Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma, Carcinoma, Embryonal, Teratoma, Endodermal Sinus Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ixabepiloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startAug 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Gnanamba V. Kondagunta, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070096
- Sponsor's protocol ID
- CDR0000329992
- Other IDs
- MSKCC-03041, NCI-6022
- Status last verified
- Apr 2006
- First submitted
- 3 Oct 2003
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL
- ClinicalTrials.gov ID
- NCT00070096
- Acronym / sponsor ID
- CDR0000329992
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
- Keywords
- stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, adult central nervous system germ cell tumor, recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Oct 2003 (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.
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.
Detailed description
OBJECTIVES:
- Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
- Determine the safety of this drug in these patients.
OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ixabepilone | Drug | – |
Primary outcome
Efficacy
Safety
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 24 Jun 2013.
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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.
Gnanamba V. Kondagunta, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ixabepilone in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by Memorial Sloan Kettering 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?
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 24 Jun 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy. The study lists 2 primary outcomes in all. 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 24 Jun 2013.