Condition or disease | Intervention/treatment | Phase |
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Adenoid Cystic Carcinoma | Drug: Tretinoin | Phase 2 |
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved all-trans retinoic acid (ATRA) for this specific disease but it has been approved for other uses.
The main purpose of this study is to see how effective all-trans retinoic acid (ATRA) is in treating tumor. Other reasons for conducting the study are:
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma |
Actual Study Start Date : | August 5, 2019 |
Actual Primary Completion Date : | April 15, 2020 |
Actual Study Completion Date : | April 15, 2020 |
Arm | Intervention/treatment |
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Experimental: Tretinoin
-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle
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Drug: Tretinoin
ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)
Other Names:
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants must have normal organ and marrow function as defined below (within 14 days prior to study registration):
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Glenn J. Hanna, MD | Dana-Farber Cancer Institute |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | June 25, 2019 | ||||||||||||||
First Posted Date ICMJE | June 27, 2019 | ||||||||||||||
Last Update Posted Date | July 21, 2020 | ||||||||||||||
Actual Study Start Date ICMJE | August 5, 2019 | ||||||||||||||
Actual Primary Completion Date | April 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Best Overall Response Rate [ Time Frame: 2 years ] | ||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | A Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma | ||||||||||||||
Official Title ICMJE | A Phase II Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma | ||||||||||||||
Brief Summary | This research is studying how safe and effective all-trans retinoic acid (ATRA), is to treat advanced adenoid cystic carcinoma (ACC). | ||||||||||||||
Detailed Description |
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved all-trans retinoic acid (ATRA) for this specific disease but it has been approved for other uses. The main purpose of this study is to see how effective all-trans retinoic acid (ATRA) is in treating tumor. Other reasons for conducting the study are:
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Adenoid Cystic Carcinoma | ||||||||||||||
Intervention ICMJE | Drug: Tretinoin
ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)
Other Names:
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Study Arms ICMJE | Experimental: Tretinoin
-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle
Intervention: Drug: Tretinoin
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
18 | ||||||||||||||
Original Estimated Enrollment ICMJE |
27 | ||||||||||||||
Actual Study Completion Date ICMJE | April 15, 2020 | ||||||||||||||
Actual Primary Completion Date | April 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03999684 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-224 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Glenn J. Hanna, Dana-Farber Cancer Institute | ||||||||||||||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | July 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |