Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00089063
First received: August 4, 2004
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.


Condition Intervention Phase
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
Biological: tyrosinase peptide
Biological: gp100 antigen
Biological: MART-1 antigen
Biological: incomplete Freund's adjuvant
Drug: Montanide ISA 51 VG
Biological: sargramostim
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Immune response [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).

  • Immune response [ Time Frame: Week 106 ] [ Designated as safety issue: No ]
    Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be drawn to display the survival and time to recurrence. The log-rank test and estimates of relative risk based on the log-rank statistics will be performed. 95% confidence intervals will be constructed for the median DFS and OS.

  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be drawn to display the survival and time to recurrence. The log-rank test and estimates of relative risk based on the log-rank statistics will be performed. 95% confidence intervals will be constructed for the median DFS and OS.


Estimated Enrollment: 40
Study Start Date: June 2004
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (vaccine therapy)
Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG SC on day 1 of weeks 0, 26, 52, 78, and 104 (total of 5 vaccinations).
Biological: tyrosinase peptide
Given SC
Biological: gp100 antigen
Given SC
Biological: MART-1 antigen
Given SC
Biological: incomplete Freund's adjuvant
Given SC
Drug: Montanide ISA 51 VG
Given SC
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (vaccine therapy, sargramostim)
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.
Biological: tyrosinase peptide
Given SC
Biological: gp100 antigen
Given SC
Biological: MART-1 antigen
Given SC
Biological: incomplete Freund's adjuvant
Given SC
Drug: Montanide ISA 51 VG
Given SC
Biological: sargramostim
Given SC
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089063

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey Weber University of Southern California
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00089063     History of Changes
Other Study ID Numbers: NCI-2012-02618, NCI-2012-02618, LAC-USC-042011, NCI-6618, LAC-USC-0A1033, CDR0000378033, 10M-03-8, 6618
Study First Received: August 4, 2004
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014