NCT00028431

Brief Summary

This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2002

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

January 4, 2002

Last Update Submit

May 20, 2014

Conditions

Melanoma

Keywords

Stage III melanomaStage IV melanomaInterleukin-12Cancer VaccinesAntineoplastic Agents, CombinedIncomplete Freund's adjuvantMonophenol MonooxygenaseMannitolAdjuvants, ImmunologicMelan-A ProteinAntigens, NeoplasmAntibodiesMelanocyte lineage-specific antigen gp100CTLA-4

Interventions

MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma
  • Completely resected disease or disease-free
  • HLA-A2.1 positive
  • Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens
  • At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy
  • WBC count at least 3,000/mm3
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 gm/dL
  • Creatinine no greater than 2.0 mg/dL
  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2.5 times upper limit of normal
  • ECOG performance status 0-1
  • Have failed alpha-interferons (patients with resected stage III disease)

You may not qualify if:

  • Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides
  • Steroid therapy or other immunosuppressive medication requirement
  • Major systemic infections (e.g., pneumonia or sepsis)
  • Coagulation or bleeding disorders
  • Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems
  • Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant)
  • History of uveitis or autoimmune inflammatory eye disease
  • Other active autoimmune disease
  • Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

MelanomaNeoplasmsDiabetes Mellitus, Insulin-Dependent, 12

Interventions

Monophenol Monooxygenase

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Catechol OxidaseMixed Function OxygenasesOxygenasesOxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • Jeffrey S. Weber, M.D., Ph.D.

    University of Southern California/Norris Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 9, 2002

Study Start

August 1, 2001

Primary Completion

January 1, 2003

Study Completion

June 1, 2005

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)