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Recurrent MelanomaPhase 2NCT00005949

Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

A Phase 2 study testing aldesleukin, gp100:209-217(210M) peptide vaccine and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
aldesleukin, gp100:209-217(210M) peptide vaccine and laboratory biomarker analysis
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Mar 2001to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 41Show fewer
  • 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
  • Lesions situated in a previously irradiated area
  • No ocular or mucosal melanoma
  • No prior or concurrent liver or brain metastases
  • Performance status - ECOG 0-1
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • LDH normal
  • Bilirubin normal
  • AST no greater than 2.5 times upper limit of normal
  • Creatinine normal
  • No congestive heart failure, angina, or symptomatic cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • No severe chronic pulmonary disease
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No primary or secondary immunodeficiency or autoimmune disease
  • No currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer
  • At least 4 weeks since prior immunotherapy
  • No prior interleukin-2
  • No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine
  • No other concurrent cytokines or growth factors
  • At least 4 weeks since prior chemotherapy
  • At least 1 month since prior systemic corticosteroids
  • No concurrent systemic, inhaled, or topical corticosteroids
  • At least 1 month since other prior immunosuppressive medication
  • No antihypertensive medications from 1 day prior until 2 days after first course

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

Other trials in United States

About this study

Official title: Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.

II. Assess response duration and progression-free intervals in these patients receiving this treatment.

OUTLINE:

Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (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 complete response (CR) receive 3 additional courses after achieving CR.

Patients are followed every 9 weeks for 3 years or until disease recurrence.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years.

Being tested
aldesleukin, gp100:209-217(210M) peptide vaccine, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aldesleukinBiological

    Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

    Given SC

  • gp100:209-217(210M) peptide vaccineBiological

    Also called G9 209-2M, gp100:209-217(210M)

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00005949
Study groupRoleWhat they receive
Treatment (gp100:209-217, aldesleukin )ExperimentalPatients 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.
Receives: Biological: aldesleukin; Biological: gp100:209-217(210M) peptide vaccine; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response rate (CR or PR)

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

Secondary outcomes (3)

  1. Response duration

    The Kaplan-Meier method will be used to estimate duration of response.

    Measured: Up to 3 years

  2. Progression-free intervals

    The Kaplan-Meier method will be used to estimate time to progression.

    Measured: Up to 3 years

  3. Immunologic response rate using ELISPOT assay

    Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2001
  3. Primary completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005949
Sponsor's protocol ID
NCI-2012-02337
Other IDs
CLB-509901, U10CA031946, CDR0000067886
Status last verified
Jan 2013
First submitted
5 Jul 2000
Last updated
16 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, gp100:209-217(210M) peptide vaccine and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response rate (CR or PR) (time frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.

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