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Melanoma (Skin)Phase 2NCT00019734

Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Phase 2 study testing aldesleukin, fowlpox virus vaccine vector 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 to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and without 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, fowlpox virus vaccine vector and vaccinia-tyrosinase vaccine
Type of treatment
Vaccines
How many people
Not given
Where
1 siteUnited States
Study dates
Jul 1999to May 2003
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:

  • Histologically confirmed metastatic melanoma that has failed standard treatment
  • No ocular or mucosal melanoma as primary site
  • Measurable disease
  • No existing brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm3
  • Platelet count at least 90,000/mm3
  • No coagulation disorder

Hepatic:

  • Bilirubin no greater than 1.6 mg/dL
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen 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 primary or secondary immunodeficiency
  • No allergy to eggs
  • No history of allergy or untoward reaction to prior smallpox vaccination

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination
  • No active systemic infections
  • No active atopic dermatitis or active or past history of eczema
  • No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds
  • Surgical scars must be healed
  • Healed surgical stomas (e.g., colostomy) allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior recombinant vaccinia or fowlpox vaccines for melanoma
  • At least 3 weeks since prior systemic biologic therapy for melanoma

Chemotherapy:

  • At least 3 weeks since prior systemic chemotherapy for melanoma

Endocrine therapy:

  • At least 3 weeks since prior systemic endocrine therapy for melanoma
  • No concurrent steroid therapy

Radiotherapy:

  • At least 3 weeks since prior systemic radiotherapy for melanoma

Surgery:

  • Prior surgery allowed

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Surgery Branch

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen

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

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous treatment.

Read the detailed description

OBJECTIVES:

  • Determine efficacy of recombinant fowlpox and vaccinia viruses encoding tyrosinase antigen, administered with or without low-dose interleukin-2 (IL-2), in terms of response, in patients with metastatic melanoma.
  • Compare the response rate in patients to this vaccination administered with high-dose IL-2 to that in similar patients on previous trials treated with high-dose IL-2 alone.
  • Determine the immunological response in patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms.

  • Arm I: Patients receive recombinant fowlpox vaccine IM on day 1 followed 4 weeks later by recombinant vaccinia vaccine IM. Treatment repeats for a minimum of 4 vaccinations.
  • Arm II: Patients receive vaccinations as in arm I plus low-dose interleukin-2 (IL-2) subcutaneously daily on days 2-13 after each vaccination.
  • Arm III: Patients receive vaccinations as in arm I plus high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 after each vaccination.

Patients with stable disease or a minor, mixed, or partial response after four immunizations (1 course) may receive a second course of the same regimen beginning 4-6 weeks after the first course. After the second course, patients with tumor regression may continue to receive treatment in the absence of unacceptable toxicity until best response is achieved.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 73 patients (13-20 for arm I, 13-20 for arm II, and 19-33 for arm III) will be accrued for this study within 2 years.

Conditions
Melanoma (Skin)
Being tested
aldesleukin, fowlpox virus vaccine vector, 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

  • fowlpox virus vaccine vectorBiological

  • 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 posted28 May 2003 (estimated)
  2. Study startJul 1999
  3. Study completionMay 2003

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
NCT00019734
Sponsor's protocol ID
CDR0000067075
Other IDs
NCI-99-C-0095, NCI-T99-0025
Status last verified
May 2007
First submitted
11 Jul 2001
Last updated
20 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, fowlpox virus vaccine vector 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 20 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 20 Jun 2013.

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