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Melanoma (Skin)Phase 2NCT00054535

Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

A Phase 2 study testing aldesleukin, recombinant fowlpox-tyrosinase vaccine and vaccinia-tyrosinase vaccine in people with Melanoma (Skin), 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

RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic… 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, recombinant fowlpox-tyrosinase vaccine and vaccinia-tyrosinase vaccine
Type of treatment
Vaccines
How many people
Not given
Where
1 siteUnited States
Study dates
Jan 2003to Sep 2004
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
  • Disease progression while receiving prior standard treatment
  • No ocular or mucosal primary site
  • No uncontrolled brain metastases

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3
  • No coagulation disorders

Hepatic

  • Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular

  • No major cardiovascular illness

Pulmonary

  • No major respiratory illness

Immunologic

  • HIV negative
  • No autoimmune disease
  • No active systemic infections
  • No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation)
  • No allergy to eggs
  • No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No close contact with the following individuals for 2 weeks after vaccinia vaccination:
  • Children under 5 years of age
  • Pregnant women
  • Individuals with prior or active eczema or other eczematoid skin disorders
  • Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • Immunosuppressed individuals
  • No active atopic dermatitis
  • No prior or active eczema
  • No active cases of the following conditions:
  • Extensive psoriasis
  • Severe acneiform rash
  • Impetigo
  • Varicella zoster
  • Burns
  • Traumatic or pruritic skin conditions
  • Open wounds
  • No unhealed surgical scars
  • Healed surgical stomas (e.g., colostomy) allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior recombinant vaccinia or fowlpox vaccines for melanoma
  • No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma
  • Prior individual tyrosinase peptides are allowed
  • No prior high-dose interleukin-2

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent oral, IV, topical, or inhaled steroids

Radiotherapy

  • Not specified

Surgery

  • Recovered from prior surgery

Other

  • Recovered from prior therapy for melanoma
  • More than 3 weeks since prior systemic therapy for melanoma
  • No other concurrent systemic therapy for melanoma

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2

RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.

Read the detailed description

OBJECTIVES:

  • Determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2.
  • Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen.

OUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. Patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course beyond achieving CR.

Patients are followed annually for at least 5 years.

PROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.

Conditions
Melanoma (Skin)
Being tested
aldesleukin, recombinant fowlpox-tyrosinase vaccine, vaccinia-tyrosinase vaccine
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

  • recombinant fowlpox-tyrosinase vaccineBiological

  • vaccinia-tyrosinase vaccineBiological

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startJan 2003
  3. Study completionSep 2004

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
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054535
Sponsor's protocol ID
CDR0000270794
Other IDs
NCI-03-C-0080, NCI-6119
Status last verified
Jul 2004
First submitted
5 Feb 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, recombinant fowlpox-tyrosinase vaccine and vaccinia-tyrosinase vaccine in people with Melanoma (Skin), 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?

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 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.

Where can I read the original study information?
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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