Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
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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 : August 3, 2020
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma (Skin) | Biological: dendritic cell-MART-1 peptide vaccine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | September 2005 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
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.
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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. |
- Optimal dose [ Time Frame: 7 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039325
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | James S. Economou, MD | Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00039325 |
Other Study ID Numbers: |
CDR0000069373 UCLA-9707074 NCI-G02-2077 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | August 3, 2020 |
Last Verified: | July 2012 |
stage IV melanoma recurrent melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |