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Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma

NCT00039325•Jonsson Comprehensive Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+12 more criteria

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.

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Key Dates

Start Date

March 1, 2002

Primary Completion Date

September 1, 2005

Completion Date

June 1, 2009

Last Updated

August 3, 2020

Enrollment

ACTUAL participants

Conditions

Melanoma (Skin)

Interventions

dendritic cell-MART-1 peptide vaccine

BIOLOGICAL

SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

NCT04079166

Malignant MelanomaMelanoma (Skin)+2 more

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COMPLETED

A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients

NCT04911998

Melanoma (Skin)Metastatic Melanoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients

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Head and Neck Melanoma; Access to Staging and Surgical Treatment

Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma