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A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies

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ClinicalTrials.gov Identifier: NCT03560882
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Joaquina Baranda, University of Kansas Medical Center

Brief Summary:
This is a window-of-opportunity trial to determine if atorvastatin given for 1 to 4 weeks at a dose of 80 milligrams per day (mg/day) is sufficient to decrease the level of conformational mutant tumor protein 53 (p53) in malignant diseases (solid tumor and relapsed Acute Myeloid Leukemia (AML)).

Condition or disease Intervention/treatment Phase
Malignant Disease Solid Tumor Acute Myeloid Leukemia Drug: Atorvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Atorvastatin in p53-Mutant and p53 Wild-Type Malignancies
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020


Arm Intervention/treatment
Experimental: Atorvastatin
Atorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial)
Drug: Atorvastatin
Atorvastatin tablet, 80mg




Primary Outcome Measures :
  1. Change in conformational mutant tumor protein 53 (p53) [ Time Frame: baseline and up to 4 weeks ]
    Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of conformation mutant p53.


Secondary Outcome Measures :
  1. Change in Ki-67 (protein) [ Time Frame: baseline and up to 4 weeks ]
    Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of Ki-67 (also known as MKI67) in the conformation mutant p53 samples.

  2. Change in caspase-3 [ Time Frame: baseline and up to 4 weeks ]
    Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of caspase-3 in the conformation mutant p53 samples.



Information from the National Library of Medicine

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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:

  • Ability of participant to understand this study, and participant to sign a written informed consent. Legally authorized representative is not allowed to sign consent for participant.
  • Participants with tumor protein 53 (TP53) immunohistochemistry (IHC)-positive tumors
  • Participants whose screening IHC shows TP53-IHC-negative including wild type (WT) and null.
  • Participants with histologic or cytologic confirmation of any malignant disease who are planning and eligible to undergo surgical resection. For participants with Solid Tumors Only
  • Participants with previously treated acute myeloid leukemia (AML) are eligible if they relapse and are in between two treatment regimens
  • No concurrent or recent (within 30 days) use of systemic therapy including chemotherapy, immunotherapy, hormonal therapy, cancer vaccine, or local therapy for the cancer.
  • Formalin-fixed paraffin-embedded (FFPE) tumor tissue deemed adequate for IHC analysis and next generation sequencing (NGS) are required. Bone marrow aspirate tissue samples from participants with AML are required.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ and marrow function
  • A negative urine or serum pregnancy test within 7 days before Day 1 dose of study medication, if female participant is of childbearing potential.
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  • Current or anticipated use of other investigational agents while participating in this study.
  • Pregnant or breast feeding.
  • Diagnosis of squamous cell cancer of the oropharynx
  • Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast), unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
  • Prior use of statins in the past 30 days.
  • History of rhabdomyolysis
  • Active liver disease
  • Participants who currently consume substantial quantities of alcohol (Male, more than 4 drinks a day, Female, more than 2 drinks a day)
  • Concurrent use of drugs associated with myopathy
  • Hypersensitivity to atorvastatin or any component of the formulation
  • Untreated hypothyroidism
  • Inability to comply with study and follow-up procedures as judged by the Investigator

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): NCT03560882


Contacts
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Contact: Kerry Hepler, RN 913-945-7552 ctnursenav@kumc.edu

Locations
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United States, Kansas
University of Kansas Cancer Center - CRC Recruiting
Fairway, Kansas, United States, 66205
Contact: Kerry Hepler, RN    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
Joaquina Baranda
Investigators
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Principal Investigator: Joaquina Baranda, MD The University of Kansas Cancer Center

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Responsible Party: Joaquina Baranda, Associate Professor University of Kansas Cancer Center - Medical Oncology, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03560882     History of Changes
Other Study ID Numbers: IIT-2018-p53Atorva
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Joaquina Baranda, University of Kansas Medical Center:
atorvastatin
p53
tumor resection

Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors