Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma

NCT01175980 | Completed Phase 2 Results

• 8 other identifiers: NCI-2012-029812009-1658474P30CA022453U01CA132123U01CA062487U01CA062502U01CA062505
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 12

Brief 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). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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; Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Stage IVB Major Salivary Gland Cancer AJCC v7; Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Stage IVC Major Salivary Gland Cancer AJCC v7; Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Tongue Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response According to RECIST 1.1 Criteria

  Objective (Best) response according to RECIST 1.1 criteria.

  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

  Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months

• Time to Recurrence (TTR)

  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)

  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)

  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)

  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

Other Outcomes (8)

• Metabolic Response by PET/CT Scan

  Up to 56 days

• Number of Patients With Flow Sort Diploid Populations of Tumor Cells From FFPE Tissue Blocks

  Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months

• Number of Patients With Flow Sort Aneuploid Populations of Tumor Cells From FFPE Tissue

  Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months

Study Arms (1)

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.

Other: Laboratory Biomarker Analysis; Drug: Vorinostat

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vorinostat)

Vorinostat DRUG

Given PO

Also known as: L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza

Treatment (vorinostat)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (12)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Veterans Administration

Cleveland, Ohio, 44106, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Ireland Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Tongue Neoplasms

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Results Point of Contact

• Title: Dr. Ulka N. Vaishampayan
• Organization: Barbara Ann Karmanos Cancer Institute

vaishamu@karmanos.org

313-576-8718

Study Officials

• Patricia LoRusso

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: August 6, 2010
• Primary Completion: June 8, 2018
• Study Completion: August 1, 2018
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Locations

CA (1); US (11)