Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00005617

Purpose

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.

Condition	Intervention	Phase
Melanoma	Biological: dendritic cell-MART-1 peptide vaccine Procedure: leukapheresis	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Study Start Date:	July 1997
Primary Completion Date:	June 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A No. DC: 10^5 Route of Immunization: ID	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.
Experimental: Group B No. DC: 10^5 Route of Immunization: IV	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.
Experimental: Group C No. DC: 10^6 Route of Immunization: ID	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.
Experimental: Group D No. DC: 10^6 Route of Immunization: IV	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.
Experimental: Group E No. DC: 10^7 Route of Immunization: ID	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.
Experimental: Group F No. DC: 10^7 Route of Immunization: IV	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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005617

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John A Glaspy, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	John Glaspy, M.D., UCLA
ClinicalTrials.gov Identifier:	NCT00005617 History of Changes
Other Study ID Numbers:	CDR0000067754, P30CA016042, UCLA-9508375, NCI-H00-0050
Study First Received:	May 2, 2000
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 12, 2012