Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00039325
First received: June 6, 2002
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: dendritic cell-MART-1 peptide vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Optimal dose [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of administering MART-1 adenovirus transduced dendritic cells [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Immunological response (peptide-specific T cell generation, skin test immunohistology) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Clinical response (disease improvement or disease progression) [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: March 2002
Study Completion Date: June 2009
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A - first dose for phase 1
A*0201 positive subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Experimental: Arm B - dose increase for phase 1
A*0201 positive subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Experimental: Arm C - A*0201+/DR*04+ subjects - Phase II
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Experimental: Arm D - A*0201+/DR*04- - phase 2
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Experimental: Arm E - A*0201-/DR*04+ - phase 2
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^7. Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.
Biological: dendritic cell-MART-1 peptide vaccine
Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10^6 (for arm A) or 10^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.

  Eligibility

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

Inclusion Criteria

  • This study is confined to adults over the age of 18 with histologically proven malignant melanoma.
  • MART-1, as assessed by either RT-PCR or by immunohistochemistry.
  • Subjects must be typed for HLA-A*0201 for the phase I part of the study, and HLA-A*0201 and/or DR*04 for the phase II part.
  • Stage with unresectable measurable melanoma (stage IV or stage III unresectable). Patients previously treated with any form of therapy (including chemotherapy, radiation therapy, immunotherapy or surgery) for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous the previous treatment was completed > 30 days prior to first vaccine.
  • Both male and female patients may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment.
  • Karnofsky Performance Status greater than or equal to 70 percent, or ECOG greater than 2.
  • No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
  • No previous evidence of opportunistic infection.
  • A minimum of 30 days must have elapsed since the completion of prior chemotherapy, immunotherapy or radiation therapy.
  • Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry:

    • Hemoglobin > 9.0 g/dl.
    • Platelets > 100,000/mm3.
    • WBC > 3,000/mm3.
    • Absolute Neutrophil Count (ANC) > 1,000/mm3.
  • Ability to give informed consent.

Exclusion Criteria

Patients who meet any one of the following criteria will be excluded from study entry:

  • Lactating females: Females of child-bearing potential (pre-menopausal) must have a negative serum beta-HCG pregnancy test (within Day -7 to Day 0).
  • Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
  • HIV-infected patients, due to concerns in the ability to stimulate an effective immune response.
  • Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
  • Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents ).
  • Patients with organ allografts.
  • Uncontrolled CNS metastasis. Patients with CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth.
  • Previous clinical evidence of an autoimmune disease.
  • Concomitant Medication and Treatment

All allowed medications or treatments should be kept to a minimum and recorded. All questions regarding concomitant medications should be referred to the study chair or investigator.

Medications and Treatments Not Allowed

  • Corticosteroids
  • Chemotherapy
  • Cyclosporin A.
  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: NCT00039325

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00039325     History of Changes
Other Study ID Numbers: CDR0000069373, P30CA016042, UCLA-9707074, NCI-G02-2077
Study First Received: June 6, 2002
Last Updated: July 27, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
stage IV melanoma
recurrent melanoma

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

ClinicalTrials.gov processed this record on September 18, 2014