NCT00003339

Brief Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2004

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

November 1, 1999

Last Update Submit

May 20, 2014

Conditions

Intraocular MelanomaMelanoma (Skin)

Keywords

recurrent intraocular melanomastage III melanomastage IV melanomarecurrent melanoma

Interventions

gp100 antigenBIOLOGICAL
incomplete Freund's adjuvantBIOLOGICAL
recombinant interleukin-12BIOLOGICAL
tyrosinase peptideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular melanoma that can be completely resected or rendered free of disease but is at high risk of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of gp100/tyrosinase expression Detectable expression of one or the other antigen not required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy, including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Beckman Research Institute, City of Hope

Duarte, California, 91010, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

MeSH Terms

Conditions

Uveal MelanomaMelanoma

Interventions

incomplete Freund's adjuvantInterleukin-12 Subunit p35

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukin-12InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jeffrey S. Weber, MD, PhD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 13, 2004

Study Start

November 1, 1998

Primary Completion

November 1, 1999

Study Completion

September 1, 2004

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(2)