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A Phase I Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors

Phase 1
18 Years
70 Years
Open (Enrolling)
Nasopharyngeal Carcinoma, Hepatocellular Carcinoma, Breast Carcinoma

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Trial Information

A Phase I Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors

Tumor infiltrating lymphocytes were isolated from tumor tissues from tumor biopsy or
operation. These TILs were cultured in human IL-2 medium for 2 to 3 weeks, and reactivated
by OKT3, irradiated feeder cells from the PBMCs of healthy donors and LCL set from
EBV-transformed normal B cells, and expanded in human IL-2 medium for another 15 days. 10e9
to 10e10 TILs were yielded. The phenotype, function and sterile were detected before these
TILs infused patients. After accepting operation or first round of routine chemotherapy and
radiotherapy, the patients were treated with autologous TILs 10e9-10e10 via intravenous in
30 min, q weekX2 weeks, and followed by two weeks with daily sc low-dose interleukine-2.

Patients will be evaluated for toxicity and immune response. Peripheral blood of patients
using multimer analysis and/or ELISPOT assays. Additional, we will be able to determine
anti-tumor effects from immunotherapy by evaluating the clinical response of patients with
stable or progressive disease at the time of TILs infusion. Lastly, we will assess
additional tumor markers in patients with relapsed/refractory disease by immunohistochemical
staining of tumor sections from previous diagnostic or therapeutic biopsy samples to
determine the incidence of additional tumor antigen targets that may be used in future

Inclusion Criteria:

- Patients with nasopharyngeal carcinoma in stage IVa or Ivb and patients with
metastatic hepatocellular carcinoma were planned for tumor biopsy or primary surgeon

- Age 18 to 70 years.

- Willing to sign a durable power of attorney

- Able to understand and sign the Informed Consent Document

- Life expectancy of greater than three months

- Patients of both genders must be willing to practice birth control from the time of
enrollment on this study and for up to four months after receiving the preparative

- Serology:

- Seronegative for HIV antibody.

- Women of child-bearing potential must have a negative pregnancy test because of
the potentially dangerous effects of the preparative chemotherapy on the fetus.

- Hematology:

- WBC (> 3000/mm(3)).

- Platelet count greater than 100,000/mm.

- Hemoglobin greater than 8.0 g/dl.

- Chemistry:

- Serum ALT/AST less or equal to 2.5 times the upper limit of normal.

- Serum creatinine less than or equal to 1.6 mg/dl.

- Total bilirubin less than or equal to 1.5 mg/dl, except in patients with
Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

Exclusion Criteria:

- Previous treatment with IL-12.

- Women of child-bearing potential who are pregnant or breastfeeding because of the
potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

- Active systemic infections, coagulation disorders or other major medical illnesses of
the cardiovascular, respiratory or immune system, myocardial infarction, cardiac
arrhythmias, obstructive or restrictive pulmonary disease.

- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency

- Concurrent opportunistic infections (The experimental treatment being evaluated in
this protocol depends on an intact immune system. Patients who have decreased immune
competence may be less responsive to the experimental treatment and more susceptible
to its toxicities).

- Concurrent systemic steroid therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• the safety and tolerability of autologous tumor infiltrating lymphocytes (TIL) in combination with Interleukin-2(IL-2) in patients with nasopharyngeal carcinoma (NPC).

Outcome Description:

Safety and tolerability will be assessed by looking at adverse events by standard NIH criteria and also by performing a Quality of Life assessment. Adverse events will be reported on the case report form. The problility of observing at least one subject experience an adverse event in a sample of 20 subjects is 0.99, if the probability of the event occurring is assumed to be 0.2. There will be 95% power to detect a change in the proportion of adverse events in the group from 0 before treatment to 0.2 after treatment.

Outcome Time Frame:

{Time Frame: 12 months}

Safety Issue:


Principal Investigator

Yi-Xin Zeng, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Hepatocellular Carcinoma
  • Breast Carcinoma
  • TIL
  • NPC
  • hepatocellular carcinoma
  • immunotherapy
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Nasopharyngeal Neoplasms