Using patients' own immune cells to fight advanced melanoma and head and neck cancer

Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

This study is testing whether using patients' own immune cells, combined with a special treatment, can help people with advanced melanoma and head and neck cancer when other treatments haven't worked.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Diego (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (La Jolla, California)
• Trial ID: NCT03991741 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of autologous tumor infiltrating lymphocytes (TILs) combined with high-dose interleukin-2 (IL-2) to treat patients with advanced melanoma and head and neck cancers. The approach involves extracting immune cells from the patient's tumor, expanding them in the laboratory, and then infusing them back into the patient while suppressing their immune system to enhance the effectiveness of the treatment. The goal is to determine if this method can improve patient outcomes in cases where conventional therapies have failed.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced melanoma or head and neck cancer who have progressed after prior systemic therapies and are not candidates for curative intent therapies.

Not a fit: Patients with early-stage cancers or those who have not received prior systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma and head and neck cancers who have limited treatment options.

How similar studies have performed: Other studies utilizing adoptive cell transfer and IL-2 have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
* Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:

  1. Not candidates for known curative intent therapy.
  2. Progressed following at least one prior systemic therapy.
  3. Have advanced melanoma unresectable stage III or stage IV
  4. Have advanced head and neck recurrent or metastatic disease
* Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
* Life expectancy of greater than 3 months.
* ECOG Performance Status of 0 or 1.
* Adequate organ and marrow function
* Seronegative for HIV antibody.
* Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
* More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
* Patient has stable or progressing disease after at least one prior treatment.
* Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy

Exclusion Criteria:

* Currently using investigational agents.
* Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
* Patient is a female of child-bearing potential who is pregnant or breastfeeding
* Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
* Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
* Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
* Patient has opportunistic infections.
* Patient has a history of coronary revascularization or ischemic symptoms.
* Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.

Where this trial is running

La Jolla, California

• UC San Diego Moores Cancer Center — La Jolla, California, United States (RECRUITING)

Study contacts

• Principal investigator: Gregory Daniels, MD, PhD — University of California, San Diego
• Study coordinator: Gregory Daniels, MD, PhD

Conditions: Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer, melanoma, metastatic, head and neck cancer, solid tumor