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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00295958
Other study ID # 060041
Secondary ID 06-C-0041NCI-754
Status Completed
Phase Phase 2
First received February 23, 2006
Last updated June 12, 2012
Start date December 2005
Est. completion date July 2008

Study information

Verified date June 2012
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

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.


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.


Other known NCT identifiers
  • NCT00263510

Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 2008
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
LMB-2 immunotoxin

MART-1 antigen

gp100 antigen

incomplete Freund's adjuvant


Locations

Country Name City State
United States NCI - Surgery Branch Bethesda Maryland
United States Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda Maryland

Sponsors (2)

Lead Sponsor Collaborator
National Institutes of Health Clinical Center (CC) National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective clinical response rate No
Secondary Changes in levels of CD4+, CD25+ regulatory T cells No
Secondary Ability of LMB-2 to augment peptide vaccination No
Secondary Toxicity Yes
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