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Melanoma (Skin)Phase 2NCT00295958

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

A Phase 2 study testing LMB-2 immunotoxin, MART-1 antigen and gp100 antigen in people with Melanoma (Skin) and Non-melanomatous Skin Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin), Non-melanomatous Skin Cancer
What is being tested?
LMB-2 immunotoxin, MART-1 antigen and gp100 antigen
How many people
26 participants
Where
2 sitesUnited States
Study dates
Dec 2005to Jul 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Bethesda, Maryland, 20892-1182

  • NCI - Surgery Branch

    Bethesda, Maryland, 20892-1201

Other trials in United States

About this study

Official title: Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma

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.

Read the 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.

Being tested
LMB-2 immunotoxin, MART-1 antigen, gp100 antigen, incomplete Freund's adjuvant
Keywords
recurrent melanoma, stage IV melanoma, skin cancer
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LMB-2 immunotoxinBiological

  • MART-1 antigenBiological

  • gp100 antigenBiological

  • incomplete Freund's adjuvantBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective clinical response rate

Secondary outcomes (3)

  1. Changes in levels of CD4+, CD25+ regulatory T cells

  2. Ability of LMB-2 to augment peptide vaccination

  3. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionJun 2006
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295958
Sponsor's protocol ID
060041
Other IDs
06-C-0041, NCI-7542, NCI-P6702, CDR0000462165
Status last verified
Jun 2012
First submitted
23 Feb 2006
Last updated
14 Jun 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LMB-2 immunotoxin, MART-1 antigen and gp100 antigen in people with Melanoma (Skin) and Non-melanomatous Skin Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective clinical response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.

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