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A Randomized Phase II Continuation Booster Trial After A Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 and ISA 51 VG With Or Without GM-CSF For Patients With Resected Stages IIB/C, III And IV Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

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Trial Information

A Randomized Phase II Continuation Booster Trial After A Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 and ISA 51 VG With Or Without GM-CSF For Patients With Resected Stages IIB/C, III And IV Melanoma


PRIMARY OBJECTIVES:

I. To evaluate immune reactivity to a tyrosinase:368-376 (370D) /gp100: 209-217
(210M)/MART-1 26-35 (27L) peptide vaccine with Montanide ISA 51 with or without GM-CSF
administered as a booster for five vaccinations over two years.

OUTLINE: This is a randomized, parallel, continuation study. Patients are stratified
according to response to prior vaccination (response to 1 peptide vs response to 2 or more
peptides). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1
antigen emulsified with Montanide ISA-51 and ISA-51 VG subcutaneously (SC) on day 1 of weeks
0, 26, 52, 78, and 104 (total of 5 vaccinations).

Arm II: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and
MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I. Patients also
receive sargramostim (GM-CSF) SC on days 1-5 of weeks 0, 26, 52, 78, and 104.

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

Patients are followed at 2-4 weeks, every 6 months for 3 years, and then annually
thereafter.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study within 1 year.


Inclusion Criteria:



- Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study
provided that

- They have received all injections with evidence of an immune response

- They have not experienced recurrence of the melanoma

- Not more than twelve months have elapsed since the final injection on either
protocol

- They experienced no grade 3 or 4 toxicity attributed to the prior vaccine
regimen

- Serum creatinine of 2.0 mg/dl or less

- Total bilirubin of 2.0 mg/dl or less

- SGOT/SGPT of 2.5 X institutional norm or less

- Total WBC of 3,000 or more

- At least 1500 granulocytes

- Hemoglobin of 9.0 gm/dl or more

- Platelet count of 100,000 per cu mm. or more

- ECOG performance status of 0 or 1

- Patients will be eligible for this trial if they have failed alpha-interferon, if it
is felt to be contraindicated due to a pre-existing medical or psychiatric condition
or if they have refused treatment with it

- Ability to read, understand and willingness to sign an IRB-approved informed consent

- Patients who have had another malignancy but with no evidence of disease for greater
than 5 years from accrual to the current trial will be eligible if it is felt they
are likely to be cured; patients with squamous or basal carcinoma of the skin or
carcinoma in situ of the cervix that have been treated with curative intent can be
accrued to this trial 30 days after treatment

Exclusion Criteria:

- Who have undergone any other systemic therapy for their melanoma, including radiation
therapy since completion of 10M-01-1 or 10M-00-4

- Have major systemic infections like pneumonia or sepsis, coagulation or bleeding
disorders, or other major medical illnesses of the gastrointestinal, cardiovascular
or respiratory systems

- Who require systemic, ocular or inhaled corticosteroids

- Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase,
MART-1 or gp100 is felt to present a risk to the fetus or a breast feeding infant;
effective birth control for men and women is required during and for four months
after the study is finished

- Who are known to be positive for hepatitis BsAg, hepatitis C antibody or HIV
antibody; since cells removed for ex vivo handling and tissue culture cannot be virus
positive, and the effects of melanoma peptides might be detrimental to HIV positive
patients, patients positive for the above viruses will not be treated on this trial

- Who have had a known allergic reaction to GM-CSF, Montanide ISA 51 (IFA) or any of
the peptides included in this protocol

- Who have a prior history of uveitis or autoimmune inflammatory eye disease, immune
hemolytic anemia or other active autoimmune disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immune response

Outcome Description:

Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Jeffrey Weber

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02618

NCT ID:

NCT00089063

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Stage IIB Melanoma
  • Stage IIC Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location

University of Southern CaliforniaLos Angeles, California  90033