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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00053391
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen

Tracking Information
First Submitted Date  ICMJE January 27, 2003
First Posted Date  ICMJE January 28, 2003
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE October 2002
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response
  • Safety
  • Tolerability
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • Tumor response
  • Recurrence rates
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title  ICMJE Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand
Brief Summary

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma.

Detailed Description

OBJECTIVES:

  • Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand, in terms of tumor-specific T-cell response, in patients with HLA-A1 and/or HLA-A2.1 positive stage III or IV melanoma.
  • Determine the safety and tolerability of these vaccinations in these patients.
  • Determine tumor response and recurrence rates in patients treated with these vaccinations.

OUTLINE: This is an open-label non-randomized study.

  • Phase I: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DCs) on day -9. DCs are pulsed separately with HLA-A1 and HLA-A2.1-restricted flu matrix peptides derived from melanoma-associated tumor antigens (MAGE-10.A2, Melan-A, MAGE-3, NY-ESO-1, gp100 antigen, and tyrosinase peptide). Half of the DCs are treated ex vivo with CD40-ligand. Patients receive the peptide-pulsed DC vaccinations subcutaneously (SC) on days 1, 14, 42, and 70 in the absence of disease progression.

Patients who show tumor response (at least stable disease) at day 98 progress to phase II of the study.

  • Phase II: Patients undergo leukapheresis as in phase I on days 102, 352, and 688. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 126, 184, 268, 356, 520, and 692.

Patients are followed for 10 years.

PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Biological: recombinant CD40-ligand
  • Biological: therapeutic autologous dendritic cells
Study Arms  ICMJE Not Provided
Publications * Gross S, Erdmann M, Haendle I, Voland S, Berger T, Schultz E, Strasser E, Dankerl P, Janka R, Schliep S, Heinzerling L, Sotlar K, Coulie P, Schuler G, Schuler-Thurner B. Twelve-year survival and immune correlates in dendritic cell-vaccinated melanoma patients. JCI Insight. 2017 Apr 20;2(8). pii: 91438. doi: 10.1172/jci.insight.91438. eCollection 2017 Apr 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
62
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV cutaneous malignant melanoma
  • HLA-A1 and/or HLA-A2 expression by serologic HLA typing

    • HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells
  • No active CNS metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 4 months

Hematopoietic

  • WBC greater than 2,500/mm^3
  • Neutrophil count greater than 1,000/mm^3
  • Lymphocyte count greater than 700/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin greater than 9 g/dL
  • No bleeding disorders

Hepatic

  • Bilirubin less than 2.0 mg/dL
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal

  • Creatinine less than 2.5 mg/dL

Cardiovascular

  • No clinically significant heart disease

Pulmonary

  • No clinically significant respiratory disease

Immunologic

  • No active systemic infection
  • No immunodeficiency disease

    • No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1
  • No active autoimmune disease including (but not limited to):

    • Lupus erythematosus
    • Autoimmune thyroiditis or uveitis
    • Multiple sclerosis
    • Inflammatory bowel disease

Other

  • Stable medical condition
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 1 month after study participation
  • No organic brain syndrome or psychiatric illness that would preclude study compliance
  • No other concurrent active malignancy
  • No other concurrent serious illness that would preclude study treatment
  • No contraindication to leukapheresis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No other concurrent immunotherapy

Chemotherapy

  • More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent corticosteroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to the spleen
  • Concurrent palliative radiotherapy allowed

Surgery

  • Recovered from prior surgery
  • No prior splenectomy
  • No prior organ allograft
  • Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed

Other

  • No other concurrent investigational drugs
  • No concurrent participation in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00053391
Other Study ID Numbers  ICMJE CDR0000258491
ERLANGEN-1490
EU-20232
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen
Study Sponsor  ICMJE University Hospital Erlangen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gerold Schuler Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
PRS Account University Hospital Erlangen
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP