search
Back to results

LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery

Primary Purpose

Melanoma (Skin), Non-melanomatous Skin Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LMB-2 immunotoxin
MART-1 antigen
gp100 antigen
incomplete Freund's adjuvant
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma, skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
  • NCI - Surgery Branch

Outcomes

Primary Outcome Measures

Objective clinical response rate

Secondary Outcome Measures

Changes in levels of CD4+, CD25+ regulatory T cells
Ability of LMB-2 to augment peptide vaccination
Toxicity

Full Information

First Posted
February 23, 2006
Last Updated
June 12, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00295958
Brief Title
LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
Official Title
Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Determine objective clinical response in patients with progressive, unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprising gp100:209-217 (210M) antigen, MART-1:27-35 antigen, and Montanide ISA-51. Secondary Determine changes in levels of CD4+, CD25+ regulatory T cells in peripheral blood before and after treatment in patients treated with this regimen. Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination in these patients. Determine the toxicity profile of this regimen in these patients. OUTLINE: Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3. Patients then receive peptide vaccinations comprising gp100:209-217 (210M) antigen emulsified in Montanide ISA-51 subcutaneously (SC), and MART-1:27-35 vaccine emulsified in Montanide ISA-51 SC on days 4, 5, 6, and 24-27 (course 1). After week 8, patients achieving tumor response may receive 1 additional course in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically in the absence of disease progression. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Non-melanomatous Skin Cancer
Keywords
recurrent melanoma, stage IV melanoma, skin cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
LMB-2 immunotoxin
Intervention Type
Biological
Intervention Name(s)
MART-1 antigen
Intervention Type
Biological
Intervention Name(s)
gp100 antigen
Intervention Type
Biological
Intervention Name(s)
incomplete Freund's adjuvant
Primary Outcome Measure Information:
Title
Objective clinical response rate
Secondary Outcome Measure Information:
Title
Changes in levels of CD4+, CD25+ regulatory T cells
Title
Ability of LMB-2 to augment peptide vaccination
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Rosenberg, MD, PhD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Surgery Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery

We'll reach out to this number within 24 hrs