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CompletedNCT00317759Updated Oct 1, 2015

Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma

A Phase 1 interventional study of therapeutic autologous lymphocytes and fludarabine phosphate in Melanoma (Skin), sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-01.

Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Ages
18 Years to 75 Years
Sex
All
01

Study summary

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.

Read the detailed description

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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage IV melanoma
  • recurrent melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 12 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • Biologicaltherapeutic autologous lymphocytes
  • Drugfludarabine phosphate
06

Study locations

1 site
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
07

References and documents

Publications

  • Wallen H, Thompson JA, Reilly JZ, Rodmyre RM, Cao J, Yee C. Fludarabine modulates immune response and extends in vivo survival of adoptively transferred CD8 T cells in patients with metastatic melanoma. PLoS One. 2009;4(3):e4749. doi: 10.1371/journal.pone.0004749. Epub 2009 Mar 9. PubMed 19270751 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00317759
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Apr 25, 2006
Start date
May 2003
Completion
Oct 2008
Last update
Oct 1, 2015

Study contacts

Cassian Yee, MD
principal investigator · Fred Hutchinson Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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