Extragonadal Germ Cell TumorPhase 2NCT00453310
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
A Phase 2 study testing sunitinib malate in people with Extragonadal Germ Cell Tumor and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma
- What is being tested?
- sunitinib malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed seminoma or nonseminoma germ cell tumors (GCT)
- Refractory or relapsed disease
- Metastatic disease
- Progressive disease after prior cisplatin-based chemotherapy AND meets 1 of the following criteria for salvage therapy:
- Not a candidate for potentially curative therapy
- Received prior high-dose chemotherapy regimens
- Declines potentially curative therapy (mediastinal GCT or primary refractory GCT)
- Measurable disease*, defined as 1 of the following:
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Elevation of alpha-fetoprotein > 15 ng/mL and/or elevation of human chorionic gonadotropin > 2.2 mIU/L
- NOTE: *Patients with radiographically measurable disease only must have ≥ 1 site that has not undergone prior irradiation
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN (unless elevated liver function abnormalities due to underlying malignancy)
- LVEF ≥ 50% by MUGA
- No grade 3 hemorrhage within the past 4 weeks
- None of the following within the past 6 months:
- Myocardial infarction
- Severe or unstable angina
- Coronary or peripheral artery bypass graft
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- No prolonged QTc interval (i.e., QTc > 450 msec for males and > 470 msec for females)
- No ongoing cardiac dysrhythmias ≥ grade 2
- No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal therapy
- No active infection
- No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance, according to the study investigator
- Not pregnant or nursing
- Negative sonogram required to exclude pregnancy
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior sunitinib malate
- More than 4 weeks since prior major surgery and recovered
- More than 4 weeks since prior radiotherapy and recovered
- Concurrent palliative radiotherapy to metastatic lesion(s) allowed provided ≥ 1 measurable lesion has not been irradiated
- No concurrent therapeutic doses of warfarin
- Low-dose oral warfarin (up to 2 mg daily) for prophylaxis and treatment or heparin products at prophylactic or treatment doses allowed
- No other concurrent investigational or approved anticancer therapies, including chemotherapy, biologic response modifiers, hormone therapy, or immunologic-based treatment
- Concurrent participation in supportive care or nontreatment trials (e.g., quality-of-life or laboratory analyses) allowed
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 Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to tumor response and duration of tumor response in patients treated with this drug.
OUTLINE: This is a open-label study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 28 days and then periodically thereafter.
- Being tested
- sunitinib malate
- Keywords
- recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian choriocarcinoma, ovarian immature teratoma, ovarian mature teratoma, recurrent malignant testicular germ cell tumor, testicular choriocarcinoma, testicular seminoma, testicular yolk sac tumor, ovarian dysgerminoma, ovarian embryonal carcinoma, ovarian yolk sac tumor, ovarian monodermal and highly specialized teratoma, ovarian polyembryoma, stage III malignant testicular germ cell tumor, ovarian mixed germ cell tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor
- Medical subject headings
- Ovarian Neoplasms, Teratoma, Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma, Endodermal Sinus Tumor, Dysgerminoma, Carcinoma, Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
| Study group | Role | What they receive |
|---|---|---|
| sunitinib malate | Experimental | The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extragonadal Germ Cell TumorStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Responsible party
- Sponsor
- Investigators
- Dean F. Bajorin, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterRobert J. Motzer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453310
- Sponsor's protocol ID
- 07-004
- Other IDs
- P30CA008748, MSKCC-07004
- Status last verified
- Sep 2015
- First submitted
- 27 Mar 2007
- Last updated
- 27 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Feldman DR, Turkula S, Ginsberg MS, Ishill N, Patil S, Carousso M, Bosl GJ, Motzer RJ. Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors. Invest New Drugs. 2010 Aug;28(4):523-8. doi: 10.1007/s10637-009-9280-2. Epub 2009 Jun 23.
PubMed 19547919
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT00453310
- Acronym / sponsor ID
- 07-004
- Keywords
- recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian choriocarcinoma, ovarian immature teratoma, ovarian mature teratoma, recurrent malignant testicular germ cell tumor, testicular choriocarcinoma, testicular seminoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Posted 27 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to tumor response and duration of tumor response in patients treated with this drug.
OUTLINE: This is a open-label study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 28 days and then periodically thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib malate | Experimental | Drug: sunitinib malateThe dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| sunitinib malate | Drug | sunitinib malate |
Primary outcome
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19547919Feldman DR, Turkula S, Ginsberg MS, Ishill N, Patil S, Carousso M, Bosl GJ, Motzer RJ. Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors. Invest New Drugs. 2010 Aug;28(4):523-8. doi: 10.1007/s10637-009-9280-2. Epub 2009 Jun 23.
Related trials for Extragonadal Germ Cell Tumor
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
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
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RecruitingPhase 2
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Germ Cell Tumor
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.
Dean F. Bajorin, MD principal investigator
Memorial Sloan Kettering Cancer Center
Robert J. Motzer, 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 sunitinib malate in people with Extragonadal Germ Cell Tumor and Ovarian Cancer, 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 27 Oct 2015. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453310, which also lists 1 linked publication.
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 27 Oct 2015.