NCT00303836

Brief Summary

This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with metastatic melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy with interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more effective treatment for metastatic melanoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

March 15, 2006

Last Update Submit

June 5, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Objective clinical response (CR or PR)

    Up to 2 years

Secondary Outcomes (3)

  • Presence of anti-tumor T cells

    Up to 2 years

  • Recovery of regulatory T cells

    Up to 2 years

  • Incidence of DLTs and SAEs graded according to CTCAE version 3.0

    Up to 2 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo apheresis and in-vitro depletion of T-regulatory cells. Patients then receive a nonmyeloablative, lymphocyte-depleting preparative regimen comprising cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2 followed by autologous T-regulatory-depleted lymphocytes IV over 20-30 minutes on day 0. Patients receive vaccination with gp100:209-217 (210M) and MART-1:27-35 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on days 0-3, 20-23, 41-44, and 62-65. Patients also receive filgrastim (G-CSF) SC beginning on day 1 and continuing until blood counts recover.

Drug: cyclophosphamideDrug: fludarabine phosphateBiological: therapeutic autologous lymphocytesProcedure: in vitro-treated peripheral blood stem cell transplantationBiological: gp100 antigenBiological: MART-1 antigenBiological: incomplete Freund's adjuvantBiological: filgrastim

Arm II

EXPERIMENTAL

Patients receive treatment as in arm I. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0-4, beginning after the lymphocyte infusion. IL-2 treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: cyclophosphamideDrug: fludarabine phosphateBiological: therapeutic autologous lymphocytesProcedure: in vitro-treated peripheral blood stem cell transplantationBiological: gp100 antigenBiological: MART-1 antigenBiological: incomplete Freund's adjuvantBiological: filgrastimBiological: aldesleukin

Interventions

cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Arm IArm II
fludarabine phosphateDRUG

Given IV

Also known as: 2-F-ara-AMP, Beneflur, Fludara
Arm IArm II
therapeutic autologous lymphocytesBIOLOGICAL

Given IV

Also known as: AL, Autologous Lymphocytes, autologous T cells
Arm IArm II
in vitro-treated peripheral blood stem cell transplantationPROCEDURE

Undergo in vitro-treated peripheral blood stem cell transplantation

Also known as: in vitro-treated PBPC transplantation, in vitro-treated PBSC, in vitro-treated peripheral blood progenitor cell transplantation, PBPC transplantation, in vitro-treated, peripheral blood progenitor cell transplantation, in vitro-treated
Arm IArm II
gp100 antigenBIOLOGICAL

Given SC

Also known as: gp100
Arm IArm II
MART-1 antigenBIOLOGICAL

Given SC

Also known as: Antigen LB39-AA, Antigen SK29-AA, MART-1, MART-1 Tumor Antigen
Arm IArm II
incomplete Freund's adjuvantBIOLOGICAL

Given SC

Also known as: IFA, ISA-51, Montanide ISA 51
Arm IArm II
filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen
Arm IArm II
aldesleukinBIOLOGICAL

Given IV

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Arm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of metastatic melanoma
  • No tumor reactive cells available for cell transfer therapy
  • Measurable disease
  • Previously treated with interleukin-2 (IL-2) and meets 1 of the following criteria:
  • No response (progressive disease)
  • Recurrent disease
  • HLA\*0201 positive
  • ECOG performance status 0 or 1
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Hemoglobin \> 8.0 g/dL
  • ALT and AST \< 3 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL if Gilbert's disease is present)
  • Creatinine ≤ 2.0 mg/dL
  • Life expectancy ≥ 3 months
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute Surgery Branch

Bethesda, Maryland, 20892-1201, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cyclophosphamidefludarabine phosphatePeripheral Blood Stem Cell Transplantationgp100 Melanoma AntigenMART-1 Antigenincomplete Freund's adjuvantmontanide ISA 51FilgrastimGranulocyte Colony-Stimulating FactoraldesleukinInterleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsMelanoma-Specific AntigensNeoplasm ProteinsAntigens, NeoplasmAntigensBiological FactorsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesInterleukinsLymphokines

Study Officials

  • Steven Rosenberg

    National Cancer Institute Surgery Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

November 1, 2005

Primary Completion

January 1, 2007

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)