Columbus, OHNCT05588453Now EnrollingIRB Ready

Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Trial in Columbus, OH

Access cutting-edge clinical stage iv cutaneous melanoma ajcc v8 treatment through this clinical trial at a research site in Columbus. Study-provided care at no cost to qualified participants.

Sponsored by Kari Kendra

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Expert Care in Columbus

Access clinical stage iv cutaneous melanoma ajcc v8 specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related clinical stage iv cutaneous melanoma ajcc v8 treatment provided free

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Check if you qualify for this clinical stage iv cutaneous melanoma ajcc v8 clinical trial in Columbus, OH

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Why Participate?

  • No-Cost Study Care

  • Local to Columbus

    Convenient for OH 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 Columbus site if eligible
  4. 4Begin participation

About This Clinical Stage IV Cutaneous Melanoma AJCC v8 Study in Columbus

This phase I/II trial tests the safety, side effects, and best dose of universal donor UD TGFbetai natural killer (NK) cells, and whether UD TGFbetai NK cells with temozolomide works to shrink tumors in patients with stage IV melanoma that has spread to the brain (metastatic to the brain). NK cells are immune cells that contribute to anti-tumor immunity by recognizing and destroying transformed or stressed cells. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving UD TGFbetai NK cell and temozolomide may work better in treating patients with stage IV melanoma.

Sponsor: Kari Kendra

Who Can Participate

Inclusion Criteria

Histologically confirmed melanoma with stage IV disease
Radiologically confirmed brain metastasis (n \>= 1) with at least one measurable central nervous system (CNS) lesion \>= 10 mm on T1-weighted gadolinium enhanced magnetic resonance imaging (MRI) and unequivocal evidence of progression
No indication for stereotactic radiotherapy
At least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation)
Absolute neutrophil count (ANC) 1 x 10\^9/L
Platelets \> 100,000/L
Hemoglobin (Hgb) \>= 10 g/dL
Creatinine =\< 1.5 x upper limit of normal (ULN)
Albumin \>= 2.5 g/dL
Serum bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN if documented liver metastases or \< 3 X ULN without liver metastasis
\> 18 years old (y/o)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Females of reproductive age must agree to the use of an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product for women. Males able to father a child must practice adequate methods of contraception or completely abstain from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment
Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the first study treatment
Patient information and written informed consent form signed

Exclusion Criteria

Planned or concurrent systemic treatment or radiation therapy
If requiring corticosteroids for cerebral edema, patients must be on a stable dose. Lowest dose of steroids needed to control CNS edema is recommended. Doses above 4 mg daily need to be cleared by principal investigator (PI) of the study
Known contra-indication to MRI
Patients with non-melanoma malignancies are excluded unless a complete remission has been achieved at least 3 years prior to study entry and no additional therapy is required or anticipated during the study period (exceptions include: non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer, in situ colon cancers, in situ cervical cancers/dysplasia, or in situ breast carcinoma)
Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
Active infection
Current active hepatic or renal disease
Pregnant women, women who are likely to become pregnant or are breastfeeding
Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological, or geographical conditions potentially hampering ability to consent, compliance with the study protocol, and follow-up schedule; those conditions should be discussed with the patient before remigration in the trial
Patients who received any other investigational drugs within the 30 days prior to screening visit
Leptomeningeal metastases diagnosed by MRI
If steroids are necessary to control symptoms related to CNS metastases, patients should be on the lowest dose of steroids necessary to control symptoms

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 Columbus?

Yes, this clinical trial (NCT05588453) has an active research site in Columbus, OH 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.

Clinical Stage IV Cutaneous Melanoma AJCC v8 Treatment Options in Columbus, OH

If you're searching for clinical stage iv cutaneous melanoma ajcc v8 treatment options in Columbus, OH, this clinical trial (NCT05588453) 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 Columbus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced clinical stage iv cutaneous melanoma ajcc v8 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 clinical stage iv cutaneous melanoma ajcc v8 clinical trials near you to find additional studies recruiting in your area.

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