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

NCT00005617 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000067754UCLA-9508375NCI-H00-0050
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

stage IV melanoma; recurrent melanoma

Study Arms (6)

Group A

EXPERIMENTAL

No. DC: 10\^5 Route of Immunization: ID

Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis

Group B

EXPERIMENTAL

No. DC: 10\^5 Route of Immunization: IV

Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis

Group C

EXPERIMENTAL

No. DC: 10\^6 Route of Immunization: ID

Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis

Group D

EXPERIMENTAL

No. DC: 10\^6 Route of Immunization: IV

Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis

Group E

EXPERIMENTAL

No. DC: 10\^7 Route of Immunization: ID

Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis

Group F

EXPERIMENTAL

No. DC: 10\^7 Route of Immunization: IV

Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis

Interventions

dendritic cell-MART-1 peptide vaccine BIOLOGICAL

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.

Group A; Group B; Group C; Group D; Group E; Group F

leukapheresis PROCEDURE

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.

Group A; Group B; Group C; Group D; Group E; Group F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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):

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• John A Glaspy, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 1997
• Primary Completion: June 1, 2002
• Last Updated: August 3, 2020

Record last verified: 2012-07

Locations

US (1)