Rochester, MNNCT05465941Now EnrollingIRB Ready

Platinum-Resistant Fallopian Tube Carcinoma Clinical Trial in Rochester, MN

Access cutting-edge platinum-resistant fallopian tube carcinoma treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by Mayo Clinic

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Expert Care in Rochester

Access platinum-resistant fallopian tube carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related platinum-resistant fallopian tube carcinoma treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Platinum-Resistant Fallopian Tube Carcinoma Study in Rochester

This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years NOTE: Because no dosing or adverse event data are currently available on the use of PLX038 in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
Histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (NOTE: Any of these diseases are referred to in this protocol as "ovarian cancer")
Recurrent high grade serous ovarian cancer that was initially platinum sensitive (i.e., had at least one platinum-free interval of at least 6 months before progression) is now platinum resistant
No more than one prior line of therapy for platinum resistant disease. NOTE: Prior poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy is allowed
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Disease that is amenable to two biopsies
Life expectancy greater \>= 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Hemoglobin \>= 8.0 g/dL (obtained =\< 28 days prior to registration)
Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration)
Total bilirubin \>= 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 28 days prior to registration)
Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration)
Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research

Exclusion Criteria

Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception
Histology other than high grade serous carcinoma
Prior treatment restrictions
Chemotherapy =\< 4 weeks prior to registration
Immunotherapy =\< 4 weeks prior to registration
Radiotherapy =\< 4 weeks prior to registration
Any other investigational therapy =\< 4 weeks prior to registration
History of prior or concurrent malignancy =\< 2 years prior to registration
Exceptions: If natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
Uncontrolled intercurrent illness including, but not limited to:
Myocardial infarction within 6 months of study entry
New York Heart Association (NYHA) class III or IV heart failure
Uncontrolled dysrhythmias or poorly controlled angina
History of serious ventricular arrhythmia (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\]) and/or factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome)
Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, Exception: Patients should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class IIB or better Exception: Patients who have received prior doxorubicin (Doxil) are eligible if asymptomatic with QTc =\< 480msec (Fridericia) and NYHA class IIB or better
Known human immunodeficiency virus (HIV) Exception: Patients on effective anti-retroviral therapy with undetectable viral load =\< 6 months prior to registration are eligible for this trial
Known hepatitis
Exception: For patients with evidence of chronic hepatitis B virus infection the HepB viral load must be undetectable on suppressive therapy, if indicated, to be eligible
Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load
Receiving any other investigational agent
History of clinically significant gastrointestinal bleeding, colitis, or gastrointestinal perforation
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (APTT) above the normal range (Exceptions: low dose deep vein thrombosis \[DVT\] or line prophylaxis allowed)
Known central nervous system (CNS) disease Exception: Patients with treated brain metastases are eligible if follow-up brain imaging after CNS directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determined that immediate CNS specific treatment is not required and is unlikely to be required during the 1st cycle of therapy
Known Gilbert's syndrome or homozygous for the UGT1A1\*28 variant allele or other relevant alleles with severely reduced UGT1A1 activity
Patients who require treatment with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT05465941) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Platinum-Resistant Fallopian Tube Carcinoma Treatment Options in Rochester, MN

If you're searching for platinum-resistant fallopian tube carcinoma treatment options in Rochester, MN, this clinical trial (NCT05465941) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced platinum-resistant fallopian tube carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all platinum-resistant fallopian tube carcinoma clinical trials near you to find additional studies recruiting in your area.

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