Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma

Phase 1

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00091143
• Lead Sponsor: Providence Cancer Center, Earle A. Chiles Research Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Infusions of a person's white blood cells may be able to replace immune cells that were destroyed by chemotherapy. Combining fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide (gp100:209-217\[210M\]), Montanide ISA-51, and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma.

* Determine the induction of antigen-specific T-cell responses in patients treated with this regimen.

* Determine the kinetics and duration of immune response in patients treated with this regimen.

* Compare the immunologic effects of this regimen in these patients with historical results.

Secondary

* Compare 2 different dosing schedules of fludarabine, in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine, in these patients.

OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms.

Within 2 weeks before the start of fludarabine, all patients undergo leukapheresis over 4-6 hours for the collection of peripheral blood mononuclear cells (PBMCs).

* Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.

* Arm II: Patients receive fludarabine as in arm I on days 1, 3, and 5. In both arms, patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and vaccination comprising gp100:209-217(210M) peptide, Montanide ISA-51, and keyhole limpet hemocyanin subcutaneously on days 8, 22, 36, 50, and 64. Patients with stable or responding disease continue to receive vaccination on day 78 and then every 28-31 days for up to 1 year.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-07
• Study First Posted: 2004-09-08
• Status Verified: 2009-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity by clinical and laboratory observation at 1 month
Antigen-specific T-cell responses by tetramer analysis, ELISPOT, and cytokine flow cytometry periodically

Secondary Outcome Measures

Name	Time	Method
Compare 2 different dosing schedules of fludarabine in terms of lymphocyte recovery using a complete blood count periodically
Tumor regression by standard imaging at study completion

Trial Locations

Locations (1)

Providence Cancer Center at Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States