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CompletedNCT00003556Updated Feb 8, 2013

Vaccine Therapy in Treating Patients With Melanoma

A Phase 1 interventional study of ALVAC-hB7.1 and canarypox-hIL-12 melanoma vaccine in Melanoma (Skin), sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-08.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery. Vaccines may make the body build an immune response that may kill tumor cells. Combining more than one vaccine may kill more tumor cells.

Read the detailed description

OBJECTIVES:

I. Determine the toxic effects associated with ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma.

II. Characterize the inflammatory and lymphokine response to this regimen in these patients.

III. Examine the extent of nodule regression, humoral immune response, and cytolytic T cell activity with this regimen in these patients.

OUTLINE: This is a dose escalation study of ALVAC-hB7.1

Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

Patients are followed at 1, 2, 4, 8, 11, 15, 22, and 43 days after the first vaccination.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage IV melanoma
  • recurrent melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 15 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma that is surgically incurable
  • At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection
  • If only one accessible lesion is available, it must be at least 2 cm
  • If two or more accessible lesions exist, then none of them are required to be at least 2 cm

PATIENT CHARACTERISTICS:

  • Age: Over 18
  • Performance status: ECOG 0-2
  • Life expectancy: Greater than 3 months
  • Leukocyte count at least 3,000/mm3
  • Platelet count at least 120,000/mm3
  • SGOT and alkaline phosphatase less than 5 times normal
  • Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis)
  • BUN less than 40 mg/dL
  • Creatinine less than 2.5 mg/dL
  • No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias
  • Not positive for hepatitis B virus
  • Not positive for HIV
  • No history of allergy to vaccinia virus
  • No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No underlying immunodeficiency disorder

PRIOR CONCURRENT THERAPY:

  • At least 30 days since prior biologic therapy (e.g., interferon or IL-2)
  • At least 30 days since prior chemotherapy
  • No concurrent steroids
  • At least 30 days since prior radiotherapy
  • Prior radiotherapy to no greater than 50% of nodal groups
  • No prior splenectomy
  • No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Arm I

    Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

    Biological: ALVAC-hB7.1 · Biological: canarypox-hIL-12 melanoma vaccine

Interventions

  • BiologicalALVAC-hB7.1
  • Biologicalcanarypox-hIL-12 melanoma vaccine
06

Study locations

1 site
  • University of Alabama Comprehensive Cancer Center
    Birmingham, Alabama 35294, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00003556
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 17, 2004
Start date
Jan 1999
Primary completion
May 2001
Last update
Feb 8, 2013

Study contacts

Robert M. Conry, MD
study chair · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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