AzTrials
AzTrials

Melanoma (Skin)Phase 1/2NCT00053391

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

A Phase 1/2 study testing recombinant CD40-ligand and therapeutic autologous dendritic cells in people with Melanoma (Skin), run by University Hospital Erlangen at 1 site in Germany.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
recombinant CD40-ligand and therapeutic autologous dendritic cells
How many people
62 participants
Where
1 siteGermany
Study dates
Oct 2002to Jun 2007
Phase
Phase 1/2
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:

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen

    Erlangen, D-91052

Other trials in Germany

About this study

Official title: 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

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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
recombinant CD40-ligand, therapeutic autologous dendritic cells
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

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

  • recombinant CD40-ligandBiological

  • therapeutic autologous dendritic cellsBiological

What is being measured

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

  1. Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response

  2. Safety

  3. Tolerability

Secondary outcomes (2)

  1. Tumor response

  2. Recurrence rates

Timeline

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

  1. First posted28 Jan 2003 (estimated)
  2. Study startOct 2002
  3. Primary completionJun 2005
  4. Study completionJun 2007

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053391
Sponsor's protocol ID
CDR0000258491
Other IDs
ERLANGEN-1490, EU-20232
Status last verified
May 2015
First submitted
27 Jan 2003
Last updated
12 May 2015
Results posted
No
Data monitoring committee
No

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):e91438. doi: 10.1172/jci.insight.91438. eCollection 2017 Apr 20.

    PubMed 28422751

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing recombinant CD40-ligand and therapeutic autologous dendritic cells in people with Melanoma (Skin), run by University Hospital Erlangen at 1 site in Germany.

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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response. The study lists 3 primary outcomes in all. 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 NCT00053391, which also lists 1 linked publication.

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 12 May 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in