NCT00295958

Brief Summary

RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal cells. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

February 23, 2006

Last Update Submit

June 12, 2012

Conditions

Melanoma (Skin)Non-melanomatous Skin Cancer

Keywords

recurrent melanomastage IV melanomaskin cancer

Outcome Measures

Primary Outcomes (1)

  • Objective clinical response rate

Secondary Outcomes (3)

  • Changes in levels of CD4+, CD25+ regulatory T cells

  • Ability of LMB-2 to augment peptide vaccination

  • Toxicity

Interventions

LMB-2 immunotoxinBIOLOGICAL
MART-1 antigenBIOLOGICAL
gp100 antigenBIOLOGICAL
incomplete Freund's adjuvantBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Unresectable disease * Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine) * HLA-A0201 positive * Measurable disease * The following are not allowed: * Resectable local/regional disease * Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (\> 75% of the activity of 1 ug/mL of LMB-2) * Received LMB-2 on another trial PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy more than 3 months * WBC ≥ 3,000/mm\^3 * Absolute lymphocyte count \> 500/mm\^3 * Platelet count ≥ 90,000/mm\^3 * Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome) * AST and ALT ≤ 2.5 times normal * Albumin ≥ 3.0 g/dL * No hepatitis B surface antigen or hepatitis C positivity * Creatinine ≤ 1.4 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No ongoing or active infection * Ejection fraction ≥ 45% by echocardiogram or thallium stress test (for patients \> 50 years of age OR who have a history of cardiovascular disease) * LVEF ≥ 45% * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No known HIV positivity * No autoimmune disease * No immunodeficiency * No other malignancies * Must be willing to undergo leukapheresis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 12 weeks since prior monoclonal antibody therapy * More than 3 weeks since prior and no concurrent systemic therapy for cancer * No concurrent chronic anticoagulant therapy * No concurrent systemic steroid therapy

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Surgery Branch

Bethesda, Maryland, 20892-1201, United States

Location

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Interventions

B3(Fv)-PE38KDEL recombinant immunotoxinMART-1 Antigenincomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific AntigensNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological Factors

Study Officials

  • Steven A. Rosenberg, MD, PhD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 24, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2006

Study Completion

July 1, 2008

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(2)