Relapsed or Cisplatin-Refractory Germ Cell CancerPhase 2NCT00371553
Phase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer
A Phase 2 study testing SU011248 (Sunitinib) in people with Relapsed or Cisplatin-Refractory Germ Cell Cancer, run by British Columbia Cancer Agency at 6 sites in Canada.
Trial summary
The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Relapsed or Cisplatin-Refractory Germ Cell Cancer
- What is being tested?
- SU011248 (Sunitinib)
- How many people
- 33 participants
- Where
- 6 sitesCanada
- Study dates
- Nov 2006to Jun 2009
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with histologically proven seminomatous or non-seminomatous germ cell cancer
- patients with relapse within 8 weeks after at least 2 different cisplatin- based regimens or
- patients with disease progression or relapse after salvage high-dose chemotherapy or patients with disease progression during cisplatin-based chemotherapy or patients with contraindications for other aggressive chemotherapy
- measurable disease
- Life expectancy of greater than 3 months
- Karnofsky Performance status > 60
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- age > 18
- adequate organ function
- Resolution of acute toxic effects of prior radiotherapy, surgical procedure or chemotherapy to NCI CTCAE Version 3.0 <= grade 1.
- Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) as defined by the institution performing the scan as assessed by multigated acquisition (MUGA) scan or echocardiography
- Signed and dated informed consent document
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Acute infection
- Uncontrolled intercurrent illness
- Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non melanomatous skin cancers) are excluded.
- Interval from last chemotherapy < 3 weeks.
- Simultaneous radiation of the only target lesion
- NCI CTCAE grade 3 hemorrhage < 4 weeks of starting the study treatment
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- Patients must not be on therapeutic anticoagulation.
- Major surgery or radiation therapy within < 4 weeks of starting the study treatment.
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- Ongoing cardiac arrhythmias of NCI CTCAE grade >= 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >500 msec on baseline EKG.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
- Current treatment on another clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta, T4N 4N2
QEII Health Science Center
Halifax, Nova Scotia, B3H 2Y9
London Regional Cancer Centre
London, Ontario, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, M5G2M9
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Prospective Open-Labeled Non Randomised Phase-II Study of SU011248 (Sunitinib) in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer - A CUOG / GTCSG Cooperative Phase II Study -
The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response.
Read the detailed description
SU011248 is a new investigational drug that has been shown to be effective against kidney cancer and other cancers in clinical trials. An investigational drug in Canada is a drug that is not yet approved for standard treatment. SU011248 inhibits enzymes (chemicals that help cells function) called tyrosine kinases, which are important enzymes for tumor growth and tumor spread in your body. If these enzymes are blocked, tumor growth may be disrupted and subsequently the cancer cell may die. SU011248 has been given to patients with kidney cancer and other cancers in clinical trials and some of them have improved, although it is not yet certain how often this occurs. There is some evidence that the enzymes inhibited by SU011248 also play an important role in the development and growth of germ cell cancers. This is the reason why SU011248 is being tested in subjects with germ cell cancers.
Objectives:
Primary:
To assess the response rate of SU011248 in patients with relapsed or cisplatin- refractory germ cell cancer.
Secondary: To assess the rate of disease stabilizations, toxicity, time to progression and response duration of SU011248 given to patients with relapsed or cisplatin-refractory germ cell cancer.
Study Drug Regimen:
SU011248 will be given at 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks. SU011248 will be orally self-administered once daily without regard to meals. Patients will remain on the study drug until disease progression.
- Being tested
- SU011248 (Sunitinib)
- Keywords
- relapsed or cisplatin-refractory germ cell cancer, germ cell cancer, SU011248 (Sunitinib)
- Medical subject headings
- Recurrence, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248 (Sunitinib)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Secondary outcomes (4)
Rate and duration of stable disease
Time to progression.
Median and 1 yr survival
Safety and tolerability of SU011248
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Cisplatin-Refractory Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urologic Oncology Group, NCIC Testis Group, German Testicular Cancer Study Group
- Investigators
- Christian K Kollmannsberger, MD, Principal investigator, BC Cancer Agency -Vancouver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371553
- Sponsor's protocol ID
- Testis protocol Version 003
- Other IDs
- CUOG-TE 05/OZM-007
- Status last verified
- Jul 2009
- First submitted
- 1 Sep 2006
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open-Labeled Non Randomised Phase-II Study of SU011248 (Sunitinib) in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer - A CUOG / GTCSG Cooperative Phase II Study -
- ClinicalTrials.gov ID
- NCT00371553
- Acronym / sponsor ID
- Testis protocol Version 003
- Keywords
- relapsed or cisplatin-refractory germ cell cancer, germ cell cancer, SU011248 (Sunitinib)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Canadian Urologic Oncology Group, NCIC Testis Group, German Testicular Cancer Study Group
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Sep 2006 (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.
The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response.
Detailed description
SU011248 is a new investigational drug that has been shown to be effective against kidney cancer and other cancers in clinical trials. An investigational drug in Canada is a drug that is not yet approved for standard treatment. SU011248 inhibits enzymes (chemicals that help cells function) called tyrosine kinases, which are important enzymes for tumor growth and tumor spread in your body. If these enzymes are blocked, tumor growth may be disrupted and subsequently the cancer cell may die. SU011248 has been given to patients with kidney cancer and other cancers in clinical trials and some of them have improved, although it is not yet certain how often this occurs. There is some evidence that the enzymes inhibited by SU011248 also play an important role in the development and growth of germ cell cancers. This is the reason why SU011248 is being tested in subjects with germ cell cancers.
Objectives:
Primary:
To assess the response rate of SU011248 in patients with relapsed or cisplatin- refractory germ cell cancer.
Secondary: To assess the rate of disease stabilizations, toxicity, time to progression and response duration of SU011248 given to patients with relapsed or cisplatin-refractory germ cell cancer.
Study Drug Regimen:
SU011248 will be given at 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks. SU011248 will be orally self-administered once daily without regard to meals. Patients will remain on the study drug until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- patients with histologically proven seminomatous or non-seminomatous germ cell cancer
- patients with relapse within 8 weeks after at least 2 different cisplatin- based regimens or
- patients with disease progression or relapse after salvage high-dose chemotherapy or patients with disease progression during cisplatin-based chemotherapy or patients with contraindications for other aggressive chemotherapy
- measurable disease
- Life expectancy of greater than 3 months
Key exclusion criteria (15 listed)
- Acute infection
- Uncontrolled intercurrent illness
- Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non melanomatous skin cancers) are excluded.
- Interval from last chemotherapy < 3 weeks.
- Simultaneous radiation of the only target lesion
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 |
|---|---|---|
| SU011248 (Sunitinib) | Drug | – |
Primary outcome
Response Rate
4 secondary outcomes
Rate and duration of stable disease
Time to progression.
Median and 1 yr survival
Safety and tolerability of SU011248
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 8 Jul 2009.
Related trials for Relapsed or Cisplatin-Refractory Germ Cell Cancer
Active, not recruitingPhase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Germ Cell Tumor, Teratoma
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.
Christian K Kollmannsberger, MD principal investigator
BC Cancer Agency -Vancouver Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SU011248 (Sunitinib) in people with Relapsed or Cisplatin-Refractory Germ Cell Cancer, run by British Columbia Cancer Agency at 6 sites in Canada.
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 12 inclusion and 15 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 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Response Rate. 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 8 Jul 2009.