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

Completed · Phase 1

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00005617

Run by

Jonsson Comprehensive Cancer Center

Starts

1997-07-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• I (<.75 to 1.5 mm or Clark level III-T1-2N0M0-)-not eligible
• II (1.5 to 4 mm or level IV-T3N0M0-)-eligible
• III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)-eligible
• IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)-eligible
• 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):
• Hemoglobin >9.0 g/dl
• Platelets > 100000/mm3
• WBC > 3000/mm3
• Absolute Neutrophil Count > 1000/mm3
• Positive skin test to common antigens (tetanus and candida)
• Ability to give informed consent

You may not qualify if…

• 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

Where it is running

• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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