NCT00005949

Brief Summary

Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2000

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

5 years

First QC Date

July 5, 2000

Last Update Submit

January 15, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Clinical response rate (CR or PR)

    From the start of treatment until disease progression/recurrence, assessed up to 3 years

Secondary Outcomes (3)

  • Response duration

    Up to 3 years

  • Progression-free intervals

    Up to 3 years

  • Immunologic response rate using ELISPOT assay

    Up to 3 years

Study Arms (1)

Treatment (gp100:209-217, aldesleukin )

EXPERIMENTAL

Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.

Biological: aldesleukinBiological: gp100:209-217(210M) peptide vaccineOther: laboratory biomarker analysis

Interventions

aldesleukinBIOLOGICAL

Given SC

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Treatment (gp100:209-217, aldesleukin )
gp100:209-217(210M) peptide vaccineBIOLOGICAL

Given SC

Also known as: G9 209-2M, gp100:209-217(210M)
Treatment (gp100:209-217, aldesleukin )
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gp100:209-217, aldesleukin )

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease
  • HLA-A2\*0201 positive by genotyping
  • Measurable disease as defined by the following:
  • At least 1 lesion accurately measured in at least 1 dimension
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
  • Lesions considered intrinsically nonmeasurable include:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukinInterleukin-2Protein Subunit Vaccines

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)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological FactorsVaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex Mixtures

Study Officials

  • John Roberts

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

March 1, 2001

Primary Completion

March 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)