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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00039325
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 2, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 6, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date October 2, 2015
Study Start Date  ICMJE March 2002
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
Optimal dose [ Time Frame: 7 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00039325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
  • Safety of administering MART-1 adenovirus transduced dendritic cells [ Time Frame: 7 months ]
  • Immunological response (peptide-specific T cell generation, skin test immunohistology) [ Time Frame: 7 months ]
  • Clinical response (disease improvement or disease progression) [ Time Frame: 7 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
Official Title  ICMJE A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: dendritic cell-MART-1 peptide vaccine
  • 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.
    Intervention: Biological: dendritic cell-MART-1 peptide vaccine
  • 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.
    Intervention: Biological: dendritic cell-MART-1 peptide vaccine
  • 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.
    Intervention: Biological: dendritic cell-MART-1 peptide vaccine
  • 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.
    Intervention: Biological: dendritic cell-MART-1 peptide vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2010)
28
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00039325
Other Study ID Numbers  ICMJE CDR0000069373
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-9707074
NCI-G02-2077
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP