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PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA


OBJECTIVES:

- Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+
antigen-specific T-cell clones in patients with metastatic melanoma.

- Estimate the duration of in vivo persistence of adoptively transferred CD8+
antigen-specific cytotoxic T-cell clones in these patients.

- Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these
patients.

OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic
T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients
receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30
minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days
1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed for approximately 1 year after the last infusion.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histopathologically proven metastatic melanoma

- No CNS metastases

- HLA-A2 positive

- Bidimensionally measurable disease by palpation on clinical exam or radiographic
imaging (x-ray, CT scan, or MRI)

- Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or
superficial node) and patient clinically eligible for such surgery

PATIENT CHARACTERISTICS:

Age

- 18 to 75

Performance status

- Karnofsky 80-100%

Life expectancy

- More than 16 weeks

Hematopoietic

- WBC greater than 4,000/mm^3

- Absolute neutrophil count greater than 2,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hematocrit greater than 30%

Hepatic

- Bilirubin no greater than 1.6 mg/dL

- SGOT no greater than 150 IU (or no greater than 3 times normal)

- Prothrombin time no greater than 1.5 times control

Renal

- Creatinine no greater than 2.0 mg/dL

- Calcium no greater than 12 mg/dL

Cardiovascular

- No congestive heart failure

- No clinically significant hypotension

- No symptoms of coronary artery disease

- No arrhythmia on EKG requiring drug therapy

Pulmonary

- No severe chronic obstructive pulmonary disease

- FEV_1 at least 1.0 L

- DLCO at least 45% of predicted

Other

- No active infection or oral temperature greater than 38.2 degrees C within 72 hours
of study

- No systemic infection requiring chronic maintenance or suppressive therapy

- HIV negative

- No history of seizures

- No retinitis or choroiditis

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use adequate contraception

- Peripheral blood samples available weekly for 4 consecutive weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since other prior immunotherapy

Chemotherapy

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

- At least 4 weeks since prior standard or investigational chemotherapy

Endocrine therapy

- At least 4 weeks since prior steroid therapy

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- At least 4 weeks since other prior investigational drug therapy and recovered

Type of Study:

Interventional

Study Design:

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:

1017.01

NCT ID:

NCT00002786

Start Date:

October 1995

Completion Date:

March 2006

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109