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Melanoma (Skin)Phase 2NCT00072085

Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

A Phase 2 study testing aldesleukin, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 2 sites 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

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
aldesleukin, gp100 antigen and incomplete Freund's adjuvant
How many people
Not given
Where
2 sitesUnited States
Study dates
Sep 2003to Jul 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic melanoma
  • Measurable disease
  • Progressive disease during or after prior standard treatment with or without interleukin-2

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3
  • Lymphocyte count greater than 500/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
  • ALT and AST less than 3 times normal
  • Hepatitis B surface antigen negative

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No symptomatic cardiac disease

Immunologic

  • No active systemic infection
  • No autoimmune disease
  • No known immunodeficiency disease
  • No known hypersensitivity to study agents
  • No form of primary or secondary immunodeficiency
  • No opportunistic infection
  • HIV negative

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior gp100 peptide vaccine

Chemotherapy

  • More than 6 weeks since prior nitrosoureas

Endocrine therapy

  • No concurrent systemic steroid therapy

Radiotherapy

  • Not specified

Surgery

  • Prior recent (within the past 3 weeks) minor surgical procedures allowed

Other

  • Recovered from prior therapy (toxicity no greater than grade 1)
  • More than 3 weeks since prior systemic anticancer therapy
  • No other concurrent systemic anticancer therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 (210M) peptide.

Secondary

  • Compare the toxicity profile of these immunizations in these patients.

OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to HLA-A2*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms.

  • Cohort 1 (HLA-A2*0201-positive patients): Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive immunization comprising recombinant gp100 protein (184V) emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1 course).
  • Arm II: Patients receive immunization comprising recombinant gp100 protein (184V) and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22, 43, and 64 (1 course).
  • Cohort 2 (HLA-A2*0201-negative patients): Patients receive immunization as in cohort 1, arm I.

In both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity.

In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2) receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3 retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment course beyond CR. Patients with progressive disease who are ineligible for IL-2 administration are removed from the study.

PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 [15-25 per treatment arm] and 15-25 for cohort 2) will be accrued for this study within 3 years.

Conditions
Melanoma (Skin)
Being tested
aldesleukin, gp100 antigen, incomplete Freund's adjuvant
Keywords
stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

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

  • aldesleukinBiological

  • gp100 antigenBiological

  • incomplete Freund's adjuvantBiological

Timeline

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

  1. First posted6 Nov 2003 (estimated)
  2. Study startSep 2003
  3. Study completionJul 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
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072085
Sponsor's protocol ID
CDR0000335441
Other IDs
NCI-03-C-0299, NCI-6210
Status last verified
May 2005
First submitted
4 Nov 2003
Last updated
19 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 2 sites 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?

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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072085.

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 19 Jun 2013.

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