High-grade Salivary Gland Mucoepidermoid CarcinomaPhase 2NCT00126607
Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
A Phase 2 study testing trastuzumab and laboratory biomarker analysis in people with High-grade Salivary Gland Mucoepidermoid Carcinoma and Recurrent Salivary Gland Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor
- What is being tested?
- trastuzumab and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed malignant high-grade (poorly differentiated or undifferentiated) salivary gland carcinoma of the head and neck (except adenoid cystic carcinoma) that is either metastatic or recurrent and is not amenable to salvage surgical resection or radiation therapy; eligible histologies are adenocarcinoma, acinic cell carcinoma, mucoepidermoid carcinoma, salivary duct carcinoma and undifferentiated carcinoma
- Patients must have tumors that car HER-2 gene amplification as determined by (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein, 2+ to 3+ level assessed by immunohistochemistry
- Patients must have measurable disease; all measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration
- Patients with known brain metastases are not eligible for this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Patients must have and must be willing to submit tumor tissue for pathology review and translational medicine studies; patients must be offered the opportunity to participate in specimen banking for future research
- Patients previously treated with chemotherapy are eligible provided that at least (28 days) has elapsed since the last course of chemotherapy was completed and patient has recovered from all toxicities
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- Prior radiation must have been completed at least 28 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator); prior surgery must have been completed at least 28 days prior to registration and all surgical adverse events must have resolved (in the opinion of the treating investigator)
- Patients must not be planning on receiving any other investigational agents, other chemotherapeutic agents, radiation therapy, or hormonal therapy while receiving treatment on this study except for steroids administered for non-disease-related conditions (e.g., insulin for diabetes)
- Patients must have a Zubrod Performance status of 0-2
- WBC count >= 2,000 ul within 28 days prior to registration
- ANC count >= 1,000/ul within 28 days prior to registration
- Platelet count >= 75,000/ul within 28 days prior to registration
- Bilirubin =< 2.5 x the institutional upper limit of normal within 28 days prior to registration
- SGOT or SGPT =< 2.5 x the institutional upper limit of normal within 28 days prior to registration
- Patients with liver metastases must have bilirubin and SGOT or SGPT =< 5 x the institutional upper limit of normal
- Serum creatinine < 2.5 x the institutional limit of normal within 28 days prior to registration
- Patients with a known history of allergic reactions to compounds of similar chemical or biologic composition to trastuzumab are not eligible
- No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
- Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method
- If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
- In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patient registration, the treating institution's name and ID number must be provided to the data operations center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
Read the detailed description
PRIMARY OBJECTIVES:
- To assess response (confirmed and unconfirmed, complete and partial response) in patients with advanced high-grade salivary gland carcinoma treated with trastuzumab.
II. To assess one-year progression-free survival and one-year overall survival for patients treated with this regimen.
III. To assess the toxicities associated with this treatment regimen in this group of patients.
IV. To measure the indicators of C-erb B2 oncoprotein expression and C-erb B2 oncogene amplification and epidermal growth factor receptor expression and explore the relationship between these markers and response, progression-free survival and overall survival in preliminary fashion.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 3 months for 1 year and every 6 months until 3 years from study entry.
- Conditions
- High-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Poorly Differentiated Carcinoma, Stage IVA Salivary Gland Cancer
- Being tested
- trastuzumab, laboratory biomarker analysis
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
Also called anti-c-erB-2, Herceptin, MOAB HER2
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (trastuzumab) | Experimental | Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: trastuzumab; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
A true response probability of 30% or greater would be of interest.
Measured: Up to 4 years
Secondary outcomes (2)
Progression-free survival
Measured: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 1 year
Overall survival
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionMay 2007
Why it stopped: Poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Salivary Gland Mucoepidermoid CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Madeleine Kane, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126607
- Sponsor's protocol ID
- NCI-2012-03172
- Other IDs
- S0431, U10CA032102, CDR0000437831
- Status last verified
- Feb 2013
- First submitted
- 2 Aug 2005
- Last updated
- 28 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
- ClinicalTrials.gov ID
- NCT00126607
- Acronym / sponsor ID
- NCI-2012-03172
- Conditions
- High-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Poorly Differentiated Carcinoma, Stage IVA Salivary Gland Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2005
- Primary completion
- May 2007 (actual)
- First posted
- 4 Aug 2005 (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.
This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
Detailed description
PRIMARY OBJECTIVES:
- To assess response (confirmed and unconfirmed, complete and partial response) in patients with advanced high-grade salivary gland carcinoma treated with trastuzumab.
II. To assess one-year progression-free survival and one-year overall survival for patients treated with this regimen.
III. To assess the toxicities associated with this treatment regimen in this group of patients.
IV. To measure the indicators of C-erb B2 oncoprotein expression and C-erb B2 oncogene amplification and epidermal growth factor receptor expression and explore the relationship between these markers and response, progression-free survival and overall survival in preliminary fashion.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 3 months for 1 year and every 6 months until 3 years from study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (trastuzumab) | Experimental | Biological: trastuzumab, Other: laboratory biomarker analysisPatients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients must have histologically or cytologically confirmed malignant high-grade (poorly differentiated or undifferentiated) salivary gland carcinoma of the head and neck (except adenoid cystic carcinoma) that is either metastatic or recurrent and is not amenable to salvage surgical resection or radiation therapy; eligible histologies are adenocarcinoma, acinic cell carcinoma, mucoepidermoid carcinoma, salivary duct carcinoma and undifferentiated carcinoma
- Patients must have tumors that car HER-2 gene amplification as determined by (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein, 2+ to 3+ level assessed by immunohistochemistry
- Patients must have measurable disease; all measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration
- Patients with known brain metastases are not eligible for this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Patients must have and must be willing to submit tumor tissue for pathology review and translational medicine studies; patients must be offered the opportunity to participate in specimen banking for future research
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| trastuzumabAlso: anti-c-erB-2, Herceptin, MOAB HER2Given IV | Biological | Treatment (trastuzumab) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (trastuzumab) |
Primary outcome
Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
Time frame: Up to 4 years
A true response probability of 30% or greater would be of interest.
2 secondary outcomes
Progression-free survival
Time frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 1 year
Overall survival
Time frame: Up to 4 years
Results and safety
The study was stopped early (reason given: Poor accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
Related trials for High-grade Salivary Gland Mucoepidermoid Carcinoma
Active, not recruitingPhase 2
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Head and Neck Cancer
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.
Madeleine Kane principal investigator
SWOG Cancer Research Network
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 trastuzumab and laboratory biomarker analysis in people with High-grade Salivary Gland Mucoepidermoid Carcinoma and Recurrent Salivary Gland Cancer, run by National Cancer Institute (NCI) 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 23 inclusion and 0 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: stopped early, as of the sponsor's last update on 28 Feb 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 was stopped early (reason given: Poor accrual.). Results are not available in the source record.
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 (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab (time frame: Up to 4 years). 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 28 Feb 2013.