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Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma


Phase 1
18 Years
75 Years
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma


OBJECTIVES:

Primary

- Determine the safety and toxicity of cellular adoptive immunotherapy comprising
autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in
patients with metastatic melanoma.

- Determine the duration of in vivo persistence of this therapy in these patients.

Secondary

- Evaluate the antitumor effects of this therapy in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and
then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive
cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer
testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2
subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks
for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who
demonstrate a clinical response after completion of the fourth course are eligible to
receive additional T-cell infusions.

Patients are followed for 9 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma

- Stage IV disease

- HLA-A1, -A2, and -A3 positive

- MAGE-1 or -3 positive by histology

- Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT
scan

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 to 75

Performance status

- Karnofsky 80-100%

Life expectancy

- More than 6 months

Hematopoietic

- Not specified

Hepatic

- Bilirubin ≤ 1.6 mg/dL

- SGOT ≤ 3 times upper limit of normal

- PT ≤ 1.5 times control

Renal

- Creatinine ≤ 2.0 mg/dL

- Calcium ≤ 12 mg/dL

Cardiovascular

- No congestive heart failure

- No clinically significant hypotension

- No symptoms of coronary artery disease

- No cardiac arrhythmias on electrocardiogram requiring drug therapy

- Patients with prior cardiovascular disease or the presence of any of the above
abnormalities undergo a cardiac evaluation, which may include a stress test and/or
echocardiogram

Pulmonary

- No clinically significant pulmonary dysfunction by medical history or physical
examination

- FEV_1 ≥ 60% of normal

- DLCO ≥ 55% (corrected for hemoglobin)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No retinitis or choroiditis

- No active infections or oral temperature greater than 38.2 degrees Celsius within the
past 72 hours

- No systemic infection requiring chronic maintenance or suppressive therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma
vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating
lymphocytes or lymphokine-activated killer cell therapy)

Chemotherapy

- At least 3 weeks since prior standard or experimental chemotherapy

- 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed

Endocrine therapy

- No concurrent systemic steroids (except for toxicity management)

Radiotherapy

- At least 3 weeks since prior radiotherapy

Surgery

- Not specified

Other

- At least 3 weeks since prior immunosuppressive therapy

- No concurrent pentoxifylline

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Cassian Yee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1588.00

NCT ID:

NCT00045149

Start Date:

October 2002

Completion Date:

June 2005

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109