Solid Tumor Malignancies
Conditions
Brief summary
The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.
Detailed description
The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives 1. To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation. 2. To identify lymphocyte clonal populations in the tissue that are specific for tumor cells 3. To identify immune reconstitution in the peripheral blood shaped by ALI. 4. To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.
Interventions
PROCEDUREAutologous lymphocyte infusion (ALI)
On the day after completing the last dose of radiation therapy, the patient will have an appointment scheduled in the Apheresis Unit for the infusion of unmunipulated cryopreserved cells. Patients will be pre medicated with acetaminophen (325-650 mg PO) and diphenhydramine (12.5-25 mg PO or IV) prior to infusion. Cells will be infused without a leukoreduction filter at a rate determined by cell volume.
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18
Exclusion criteria
Prior radiotherapy to the chest Life expectancy\<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI | 6 weeks +/- 14 days after ALI | Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation. | Baseline to 6 weeks | 1. Grades 3-5 allergic reactions related to ALI 2. Grade 3-5 organ toxicity 3. Treatment-related death |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGheath Al-Atrash
MD Anderson Cancer Center, Houston, Texas
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 19 |
| other Total, other adverse events | 6 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
None listed