Is NCT06483048 recruiting in Scottsdale, AZ?

Yes, NCT06483048 is currently recruiting participants at its Scottsdale, AZ location. This platinum-resistant fallopian tube carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Scottsdale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Platinum-Resistant Fallopian Tube Carcinoma Clinical Trial in Scottsdale, AZ

Q: How do I join the platinum-resistant fallopian tube carcinoma clinical trial in Scottsdale?

To join this clinical trial in Scottsdale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Platinum-Resistant Fallopian Tube Carcinoma Study in Scottsdale

This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

PRE-REGISTRATION: Age ≥ 18 years

PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer

PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET/CT

Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler

PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \< 183 days after the last dose of platinum-based chemotherapy:

Development of measurable disease (per RECIST 1.1)

Progression of radiographic disease (per RECIST 1.1)

Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \[WNL\] at the completion of platinum-based chemotherapy)

Increase in CA-125 level to ≥ 2 x nadir (if nadir \> ULN)

If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval

PRE-REGISTRATION: Provide written informed consent

PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research

REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma

REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study

REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months

REGISTRATION: Willingness and ability to provide written informed consent

REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study

REGISTRATION: Willing to undergo leukapheresis for blood component collection

REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (performed ≤ 14 days prior to registration)

REGISTRATION: Lymphocyte count ≥ 1500/mm\^3 (performed ≤ 14 days prior to registration)

REGISTRATION: Hemoglobin ≥ 8.0 g/dL (performed ≤ 14 days prior to registration)

REGISTRATION: Platelet count ≥ 30,000/mm\^3 (performed ≤ 14 days prior to registration)

REGISTRATION: Total bilirubin ≤ 2.0 mg/dL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)

Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)

REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \[DVT\]/pulmonary embolism \[PE\] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)

REGISTRATION: Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)

REGISTRATION: Baseline oxygen saturation ≥ 90% on room air

REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration

Exclusion Criteria

Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \> 30 days, and not requiring steroid therapy for \> 14 days

Prior treatment targeting MUC1

Subjects with known plasma cell leukemia (PCL)

Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and/or teratogenic effects:

Pregnant persons

Nursing persons

Persons of childbearing potential who are unwilling to employ adequate birth control measures

History of myocardial infarction ≤ 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator to control life-threatening arrhythmias

Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.

Uncontrolled concurrent illness including, but not limited to:

Inability to clear an ongoing or active infection

Symptomatic congestive heart failure

Unstable angina pectoris

Uncontrolled psychiatric problems

Inability to have a caregiver for active oversight during treatment period

Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy

Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements

Evidence of clinical immunocompromise and/or HIV positivity and currently receiving antiretroviral therapy

Patients requiring chronic supraphysiologic daily doses of steroids (\> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)

Patients receiving any other investigational agent which could be considered a treatment for the neoplasm

Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence

Diagnosis of autoimmune disease

Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded

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 Scottsdale?

Yes, this clinical trial (NCT06483048) has an active research site in Scottsdale, AZ 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 Scottsdale, AZ

If you're searching for platinum-resistant fallopian tube carcinoma treatment options in Scottsdale, AZ, this clinical trial (NCT06483048) 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 Scottsdale 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.

Platinum-Resistant Fallopian Tube Carcinoma Clinical Trial in Scottsdale, AZ

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