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Vaccine Therapy in Treating Patients With Stage IV or Relapsed 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: NCT00005617
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 2, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date August 3, 2020
Study Start Date  ICMJE July 1997
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
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 Relapsed Malignant Melanoma
Official Title  ICMJE A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.

Detailed Description

OBJECTIVES:

  • Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma.
  • Determine the immunological and clinical responses in this patient population after this therapy.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28.

Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • Biological: dendritic cell-MART-1 peptide vaccine
    Number DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group.
  • Procedure: leukapheresis
    Patients require a single leukapheresis to obtain 2x10^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups.
Study Arms  ICMJE
  • Experimental: Group A
    No. DC: 10^5 Route of Immunization: ID
    Interventions:
    • Biological: dendritic cell-MART-1 peptide vaccine
    • Procedure: leukapheresis
  • Experimental: Group B
    No. DC: 10^5 Route of Immunization: IV
    Interventions:
    • Biological: dendritic cell-MART-1 peptide vaccine
    • Procedure: leukapheresis
  • Experimental: Group C
    No. DC: 10^6 Route of Immunization: ID
    Interventions:
    • Biological: dendritic cell-MART-1 peptide vaccine
    • Procedure: leukapheresis
  • Experimental: Group D
    No. DC: 10^6 Route of Immunization: IV
    Interventions:
    • Biological: dendritic cell-MART-1 peptide vaccine
    • Procedure: leukapheresis
  • Experimental: Group E
    No. DC: 10^7 Route of Immunization: ID
    Interventions:
    • Biological: dendritic cell-MART-1 peptide vaccine
    • Procedure: leukapheresis
  • Experimental: Group F
    No. DC: 10^7 Route of Immunization: IV
    Interventions:
    • Biological: dendritic cell-MART-1 peptide vaccine
    • Procedure: leukapheresis
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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults over the age of 18 with malignant melanoma.
  • HLA-A2.1 positive and express MART-1, as assessed by either RT-PCR or by immunohistochemistry
  • Tumor stages T3N0M0 or greater are eligible for this trial according to the following:

    1. I (<.75 to 1.5 mm or Clark level III-T1-2N0M0-)-not eligible
    2. II (1.5 to 4 mm or level IV-T3N0M0-)-eligible
    3. III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)-eligible
    4. IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)-eligible
    5. Relapsed melanoma-eligible
  • Patients previously treated with any form of therapy for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous treatment was completed >30 days prior to enrollment
  • Both male and females may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment
  • Karnofsky Performance Status greater than or equal to 70 percent
  • 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 (day -30 to 0):

    1. Hemoglobin >9.0 g/dl
    2. Platelets > 100000/mm3
    3. WBC > 3000/mm3
    4. Absolute Neutrophil Count > 1000/mm3
  • Positive skin test to common antigens (tetanus and candida)
  • Ability to give informed consent

Exclusion Criteria:

  • Lactating females and females of child-bearing potential must have negative serum beta-HCG pregnancy test
  • Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days of prior to study treatment
  • HIV-infected patients
  • 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 used in this study)
  • 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
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 NCT00005617
Other Study ID Numbers  ICMJE CDR0000067754
UCLA-9508375
NCI-H00-0050
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 Not Provided
Investigators  ICMJE
Principal Investigator: John A Glaspy, 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