Recurrent Oral Cavity Adenoid Cystic CarcinomaPhase 2NCT01175980
Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
A Phase 2 study testing Laboratory Biomarker Analysis and Vorinostat in people with Recurrent Oral Cavity Adenoid Cystic Carcinoma and Recurrent Salivary Gland Carcinoma, run by National Cancer Institute (NCI) at 12 sites in 2 countries.
Trial summary
This phase II trial studies how well vorinostat works in treating patients with adenoid cystic carcinoma that has come back (recurrent) or that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Oral Cavity Adenoid Cystic Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Adenoid Cystic Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis and Vorinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 6 Aug 2010to 1 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed locally advanced, recurrent or metastatic adenoid cystic carcinoma
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm by chest x-ray, as >= 10 mm with CT scan, or >= 10 mm with calipers by clinical exam; all tumor measurements must be recorded in millimeters (or decimal fractions of centimeters)
- Patients must have locally advanced and/or recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy; any prior number of chemotherapy regimens is allowed; a minimum of at least 4 weeks since prior chemotherapy or radiation therapy should have elapsed, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C
- Life expectancy of greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%)
- Leukocytes >= 3,000/mcL
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- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits (WNL)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
- Creatinine within normal institutional limits or
- Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of vorinostat will be determined following review of their case by the principal investigator
- No other diagnosis of malignancy unless non-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed >= 5 years previously and currently with no evidence of disease; however - if the patient has had a previously diagnosed stage I/II malignancy of another type, consideration for recruitment may be made by the Cancer Therapy Evaluation Program (CTEP) senior investigator after discussion with local principal investigator (PI) and patient's physician
- Confirmed availability of tumor tissue (either fresh or from paraffin block) from the primary tumor or metastatic site to be available to use on correlative studies
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- If the patient's tumor can be easily accessed, a pre-treatment biopsy will be mandatory
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; more than 21 days from major surgery should have elapsed before the first dose of the study drug
- Patients may not be receiving any other investigational agents or have received vorinostat in the past; patients should not have taken valproic acid for at least 4 weeks prior to enrollment
- Inability to take oral medications on a continuous basis
- Patients with active brain metastases should be excluded from this clinical trial; patients with previous brain metastases will be eligible if condition is treated and stable for >= 1 month
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vorinostat
- Patient is unable or unwilling to abide by the study protocol and to cooperate fully with the investigator or designee
- Patient on current therapy with enzyme-inducing anticonvulsants
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Case Western Reserve University
Cleveland, Ohio, 44106
Cleveland Veterans Administration
Cleveland, Ohio, 44106
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
Yale University
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870
City of Hope South Pasadena
South Pasadena, California, 91030
Canada1 site
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Subjects With Locally Advanced, Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
This phase II trial studies how well vorinostat works in treating patients with adenoid cystic carcinoma that has come back (recurrent) or that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy by means of response rate (based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) of vorinostat in the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC).
SECONDARY OBJECTIVES:
- To characterize the safety and tolerability of vorinostat in this patient population.
II. To assess the time to tumor response (TTR). III. To assess the response duration (RD). IV. To evaluate progression free survival (PFS). V. To assess overall survival (OS).
TERTIARY OBJECTIVES:
- To assess the association between a metabolic response by positron emission tomography (PET)/computed tomography (CT) after one cycle of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST).
II. To assess the association between a metabolic response by PET/CT after the first and second chemotherapy cycle and PFS.
III. To assess flow sort diploid, aneuploid, and tetraploid populations of tumor cells from formalin fixed, paraffin-embedded (FFPE) tissue blocks from patients who benefited from suberoylanilide hydroxamic acid (SAHA) therapy and from patients who did not demonstrate a durable benefit.
IV. Profile the genomes of each cell population using oligonucleotide comparative genomic hybridization (CGH) arrays.
- Perform whole exome analysis of the sorted tumor population and matching germ line sample for each of the patients selected.
VI. To assess stable disease duration (SDD). VII. To assess the association between response to vorinostat treatment and RAD23 homolog B (HR23B) on tumor paraffin blocks.
VIII. Retrospectively compare volumetric density (viable tumor volume = VTV) with pre-determined RECIST of target lesions in cross sectioning imaging (CT/magnetic resonance [MR]) already obtained.
IX. Correlate VTV, RECIST and treatment response (partial response, stable disease, progressive disease and stable disease over 6 months).
OUTLINE:
Patients receive vorinostat orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 180 days.
- Conditions
- Recurrent Oral Cavity Adenoid Cystic Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Adenoid Cystic Carcinoma, Stage III Major Salivary Gland Cancer AJCC v7, Stage III Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7, Stage IVA Major Salivary Gland Cancer AJCC v7
- Being tested
- Laboratory Biomarker Analysis, Vorinostat
- Medical subject headings
- Salivary Gland Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
VorinostatDrug
Also called L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (vorinostat) | Experimental | Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response According to RECIST 1.1 Criteria
Objective (Best) response according to RECIST 1.1 criteria.
Measured: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Secondary outcomes (5)
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity.
Measured: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Time to Recurrence (TTR)
TTR will be summarized descriptively, reporting N, median, mean, standard deviation, standard error (SE), minimum, maximum, and 90% CI for the mean calculated from the SE and asymptotic normal distribution theory.
Measured: From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Response Duration (RD)
Median point estimate and full range will be documented, since only two patients achieved a response.
Measured: From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 months
Progression-free Survival (PFS)
Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both median point estimate and 90% confidence interval (CI) estimate.
Measured: From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 months
Overall Survival (OS)
Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both point and 90% CI estimates of various statistics of interest can be calculated (e.g., median, 6-month event-free rate, 12-month event-free rate, etc.). Statistical graphs of each K-M curve (with 90% CI lines) will be generated for visual display.
(One year survival rate will be given since OS median was not reached due to too few events)
Measured: From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study start6 Aug 2010
- Primary completion8 Jun 2018
- Study completion1 Aug 2018
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.
- Other trials for Recurrent Oral Cavity Adenoid Cystic 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patricia LoRusso, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175980
- Sponsor's protocol ID
- NCI-2012-02981
- Other IDs
- NCI-2012-02981, 2009-165, 8474, 8474, P30CA022453, U01CA132123, U01CA062487, U01CA062502
- Status last verified
- Jul 2020
- First submitted
- 4 Aug 2010
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Subjects With Locally Advanced, Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
- ClinicalTrials.gov ID
- NCT01175980
- Acronym / sponsor ID
- NCI-2012-02981
- Conditions
- Recurrent Oral Cavity Adenoid Cystic Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Adenoid Cystic Carcinoma, Stage III Major Salivary Gland Cancer AJCC v7, Stage III Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7, Stage IVA Major Salivary Gland Cancer AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Aug 2010 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Posted 3 Aug 2020
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 studies how well vorinostat works in treating patients with adenoid cystic carcinoma that has come back (recurrent) or that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy by means of response rate (based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) of vorinostat in the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC).
SECONDARY OBJECTIVES:
- To characterize the safety and tolerability of vorinostat in this patient population.
II. To assess the time to tumor response (TTR). III. To assess the response duration (RD). IV. To evaluate progression free survival (PFS). V. To assess overall survival (OS).
TERTIARY OBJECTIVES:
- To assess the association between a metabolic response by positron emission tomography (PET)/computed tomography (CT) after one cycle of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST).
II. To assess the association between a metabolic response by PET/CT after the first and second chemotherapy cycle and PFS.
III. To assess flow sort diploid, aneuploid, and tetraploid populations of tumor cells from formalin fixed, paraffin-embedded (FFPE) tissue blocks from patients who benefited from suberoylanilide hydroxamic acid (SAHA) therapy and from patients who did not demonstrate a durable benefit.
IV. Profile the genomes of each cell population using oligonucleotide comparative genomic hybridization (CGH) arrays.
- Perform whole exome analysis of the sorted tumor population and matching germ line sample for each of the patients selected.
VI. To assess stable disease duration (SDD). VII. To assess the association between response to vorinostat treatment and RAD23 homolog B (HR23B) on tumor paraffin blocks.
VIII. Retrospectively compare volumetric density (viable tumor volume = VTV) with pre-determined RECIST of target lesions in cross sectioning imaging (CT/magnetic resonance [MR]) already obtained.
IX. Correlate VTV, RECIST and treatment response (partial response, stable disease, progressive disease and stable disease over 6 months).
OUTLINE:
Patients receive vorinostat orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 180 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (vorinostat) | Experimental | Other: Laboratory Biomarker Analysis, Drug: VorinostatPatients receive vorinostat PO QD on days 1-28. 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 (18 listed)
- Patients must have histologically or cytologically confirmed locally advanced, recurrent or metastatic adenoid cystic carcinoma
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm by chest x-ray, as >= 10 mm with CT scan, or >= 10 mm with calipers by clinical exam; all tumor measurements must be recorded in millimeters (or decimal fractions of centimeters)
- Patients must have locally advanced and/or recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy; any prior number of chemotherapy regimens is allowed; a minimum of at least 4 weeks since prior chemotherapy or radiation therapy should have elapsed, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C
- Life expectancy of greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%)
Key exclusion criteria (9 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; more than 21 days from major surgery should have elapsed before the first dose of the study drug
- Patients may not be receiving any other investigational agents or have received vorinostat in the past; patients should not have taken valproic acid for at least 4 weeks prior to enrollment
- Inability to take oral medications on a continuous basis
- Patients with active brain metastases should be excluded from this clinical trial; patients with previous brain metastases will be eligible if condition is treated and stable for >= 1 month
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (vorinostat) |
| VorinostatAlso: L-001079038, MSK-390, SAHA, Suberanilohydroxamic AcidGiven PO | Drug | Treatment (vorinostat) |
Primary outcome
Objective Response According to RECIST 1.1 Criteria
Time frame: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Objective (Best) response according to RECIST 1.1 criteria.
5 secondary outcomes
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Time to Recurrence (TTR)
Time frame: From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Response Duration (RD)
Time frame: From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 months
Progression-free Survival (PFS)
Time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 months
Overall Survival (OS)
Time frame: From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patricia LoRusso principal investigator
Barbara Ann Karmanos Cancer Institute
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis and Vorinostat in people with Recurrent Oral Cavity Adenoid Cystic Carcinoma and Recurrent Salivary Gland Carcinoma, run by National Cancer Institute (NCI) at 12 sites in 2 countries.
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 18 inclusion and 9 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, 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?
Yes. Results are posted in the registry (first posted 3 Aug 2020). 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?
Objective Response According to RECIST 1.1 Criteria (time frame: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months). 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 3 Aug 2020.