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Trial record 1 of 128 for:    Adenoid Cystic Carcinoma
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A Trial of All-trans Retinoic Acid (ATRA) in Advanced Adenoid Cystic Carcinoma

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ClinicalTrials.gov Identifier: NCT03999684
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
The V Foundation
ACCRF
Information provided by (Responsible Party):
Glenn J. Hanna, Dana-Farber Cancer Institute

Brief Summary:
This research is studying how safe and effective all-trans retinoic acid (ATRA), is to treat advanced adenoid cystic carcinoma (ACC).

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Drug: Tretinoin Phase 2

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:

  • To determine for how long all-trans retinoic acid (ATRA) may reduce the size or slow down the growth of tumor
  • To evaluate levels of circulating tumor DNA (ctDNA) released in the bloodstream as an indication of the disease activity
  • To better understand mechanisms of tumor resistance to ATRA

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
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
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
Drug Information available for: Tretinoin

Arm Intervention/treatment
Experimental: Tretinoin
-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle
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:
  • Tretin-X
  • ATRA




Primary Outcome Measures :
  1. Best Overall Response Rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Complete Response [ Time Frame: 2 years ]
  2. Partial Response [ Time Frame: 2 years ]
  3. Progression Free Survival [ Time Frame: 2 Years ]
  4. Duration Of Therapeutic Response [ Time Frame: 2 years ]
  5. The Inhibitory Effect of Tretinoin on MYB Expression in ACC Tumors [ Time Frame: 2 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically confirmed adenoid cystic carcinoma with evidence of recurrent, metastatic or advanced, unresectable disease that is not amenable to curative surgery with or without radiotherapy.
  • Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) equal to or greater than 1 cm with CT scans or MR imaging.
  • Participants must be willing to undergo fresh tissue core needle biopsy prior to study registration and repeat tumor biopsy while on study for correlatives. Willingness to provide blood samples for research throughout the study is also required.
  • Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (4 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤ 1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent/metastatic ACC are permitted.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).
  • Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and/or new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria is not required.
  • Participants must have normal organ and marrow function as defined below (within 14 days prior to study registration):

    • leukocytes ≥ 3,000/mcL
    • absolute neutrophil count ≥ 1,500/mcL
    • hemoglobin ≥ 9 g/dL without transfusion within 7 days of treatment
    • platelets ≥ 100,000/mcL
    • total bilirubin ≤ 2x upper limit of normal (ULN)
    • AST(SGOT)/ALT(SGPT) ≤ 2.5x institutional ULN or ≤ 5x ULN for those with liver metastases
    • serum creatinine ≤ 1.5x ULN OR
    • creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5x ULN
    • coagulation profile INR ≤ 1.5x ULN unless the participant is receiving an anticoagulant
    • triglyceride level < 500 mg/dL or < 5.7 mmol/L
    • cholesterol level < 400 mg/dL or < 10.34 mmol/L
  • Baseline tumor measurements must be documented from imaging within 28 days prior to study registration. Other non-laboratory tests must be performed within 28 days prior to study registration.
  • Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female and male subjects of childbearing potential must agree to use an adequate method of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of tretinoin administration. Contraception is required before starting the first dose of study medication through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. There is a significant risk of fetal malformation if pregnancy occurs while on tretinoin at any dose level, even if for short exposure periods.
  • Be willing and able to provide written informed consent for the trial.

Exclusion Criteria:

  • Metastatic disease impinging on the spinal cord or threatening spinal cord compression. Patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible.
  • Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability, because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Subjects who are pregnant, or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Pregnant women are excluded from this study because tretinoin has the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999684


Contacts
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Contact: Glenn J. Hanna, MD 617-582-7323 glenn_hanna@dfci.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jong Chul Park, MD    617-724-4000    jpark73@mgh.harvard.edu   
Principal Investigator: Jong Chul Park, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Glenn J. Hanna, MD    617-582-7323    glenn_hanna@dfci.harvard.edu   
Principal Investigator: Glenn J. Hanna, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
The V Foundation
ACCRF
Investigators
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Principal Investigator: Glenn J. Hanna, MD Dana-Farber Cancer Institute

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Responsible Party: Glenn J. Hanna, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03999684     History of Changes
Other Study ID Numbers: 19-224
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenn J. Hanna, Dana-Farber Cancer Institute:
Adenoid Cystic Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents