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Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion 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 Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma


OBJECTIVES:

Primary

- Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+
antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with
stage IV melanoma.

- Determine the duration of in vivo persistence of these CTL clones in these patients.

Secondary

- Determine the antitumor effect of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood
mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL)
clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over
30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable
toxicity. Patients also receive fludarabine IV once daily on days 14-18.

Patients are followed for up to 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma

- Stage IV disease

- HLA-A2 or -A3-expressing disease

- Bidimensionally measurable residual disease by palpation or radiographic imaging
(e.g., x-ray or CT scan)

- No CNS metastases

- Previously treated CNS involvement allowed provided there is no evidence of CNS
disease at least 2 months after completion of therapy

PATIENT CHARACTERISTICS:

Age

- 18 to 75

Performance status

- Karnofsky 80-100%

Life expectancy

- More than 6 months

Hematopoietic

- Platelet count > 100,000/mm^3

- Absolute neutrophil count > 2,000/mm^3

Hepatic

- SGOT no greater than 3 times upper limit of normal

- Bilirubin no greater than 1.6 mg/dL

- INR no greater than 1.5 times normal

Renal

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular

- No congestive heart failure

- No clinically significant hypotension

- No symptoms of coronary artery disease

- No cardiac arrhythmia by EKG requiring drug therapy

Pulmonary

- No clinically significant pulmonary dysfunction

- FEV_1 at least 1.0 L*

- DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction

Immunologic

- No active infection

- No oral temperature greater than 38.2°C within the past 48 hours

- No systemic infection requiring chronic maintenance or suppressive therapy

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

- At least 3 weeks since prior chemotherapy (standard or experimental)

Endocrine therapy

- No concurrent steroids

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:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1796.00

NCT ID:

NCT00317759

Start Date:

May 2003

Completion Date:

October 2008

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109