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MelanomaPhase 1NCT00683670

Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

A Phase 1 study testing cyclophosphamide and Mature dendritic cell vaccine in people with Melanoma, run by University of Pennsylvania at 1 site 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

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
cyclophosphamide and Mature dendritic cell vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Aug 2008to Jun 2016
Phase
Phase 1
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

Who may be able to join

  • Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
  • Age ≥ 18 years
  • Life expectancy ≥ 4 months
  • ECOG performance status 0-2
  • At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted
  • Required initial laboratory values (submitted within 14 days prior to registration):
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  • WBC >3,000/mm3
  • Hg ≥ 9.0 gm/dl
  • Platelets >75,000/mm3
  • Serum Bilirubin < 2.0 mg/dl
  • Serum Creatinine < 2.0 mg/dl
  • Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.

Who cannot join

  • Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted.
  • Active untreated CNS metastasis
  • Active infection
  • Prior malignancy (except non-melanoma skin cancer) within 3 years
  • Pregnant or nursing
  • Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted.
Show all 10Show fewer
  • Inability to provide adequate informed consent
  • Known allergy to eggs
  • Prior history or uveitis or autoimmune inflammatory eye disease.
  • Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Read the detailed description

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All patients will receive mature DC for each dose of vaccine. For each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides. All patients will receive booster doses with mature DC. The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging is performed after three and six vaccine doses. Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

Conditions
Melanoma
Being tested
cyclophosphamide, Mature dendritic cell vaccine
Medical subject headings
Melanoma

What participants receive

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

Study groups in NCT00683670
Study groupRoleWhat they receive
Dendritic Cell Vaccine (First Group)ExperimentalBlood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
Receives: Drug: cyclophosphamide; Biological: Mature dendritic cell vaccine
Dendritic Cell Vaccine (Second Group)ExperimentalBlood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
Receives: Drug: cyclophosphamide; Biological: Mature dendritic cell vaccine
Dendritic Cell Vaccine (Third Group)ExperimentalBlood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 6 weeks for a total of 3 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 in order to collect PBMC for immune monitoring.
Receives: Drug: cyclophosphamide; Biological: Mature dendritic cell vaccine

What is being measured

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

  1. Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.

    • Starting on Day 0, two tubes will be drawn weekly until Day 64. Thereafter, two tubes will be drawn every 21 days until Day 190. For patients receiving maintenance treatment, blood is drawn every month.
    • Data are presented as the percentage of CD8+ T cells positive for tetramer binding based on gating variables set using the iMASC reagent kit (Beckman Coulter).

    Measured: Through completion of treatment

  2. Safety and tolerability of the mature dendritic cell vaccine as measured by adverse events

    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

    Measured: 30 days after end of treatment

Secondary outcomes (4)

  1. Time to progression

    Measured: Through completion of treatment or until progressive disease

  2. Regulatory T cell depletion after cyclophosphamide administration.

    Regulatory T cells (Treg) are defined as CD4+CD25+foxP3+ (triple positive) cells. At the indicated time points, the percentage of Treg cells is determined by 3 color flow cytometry. The depletion of Treg is defined as follows [Treg baseline - Treg nadir/ Treg baseline x 100= % depletion].

    Measured: Day -3 (72 hours prior to vaccine dose 1)

  3. Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.

    Measured: Day 0 (prior to vaccine dose 1)

  4. Clinical response rate using RECIST criteria

    Measured: After third vaccine, sixth vaccine, and then every 8 weeks

Timeline

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

  1. First posted23 May 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJun 2016
  4. Study completionJun 2016

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00683670
Sponsor's protocol ID
07-0652 / 826850
Status last verified
Jun 2025
First submitted
19 May 2008
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jemal, A., T. Murray, E. Ward, A. Samuels, R.C. Tiwari, A. Ghafoor, E.J. Feuer, and M.J. Thun. 2007. Cancer statistics, 2007. CA Cancer J Clin 57:42-59.

  • Lotze, M.T., R.M. Dallal, J.M. Kirkwood, and J.C. Flickinger. 2001. Cutaneous Melanoma. In Cancer:Principles and Practice of Oncology. V.T. DeVita, S. Hellman, and S.A. Rosenberg, editors. Lippincott, Williams, & Wilkins, Philadelphia. 2012-2069.

  • Eggermont AM, Kirkwood JM. Re-evaluating the role of dacarbazine in metastatic melanoma: what have we learned in 30 years? Eur J Cancer. 2004 Aug;40(12):1825-36. doi: 10.1016/j.ejca.2004.04.030.

    PubMed 15288283

  • Queirolo P, Acquati M, Kirkwood JM, Eggermont AM, Rocca A, Testori A. Update: current management issues in malignant melanoma. Melanoma Res. 2005 Oct;15(5):319-24. doi: 10.1097/00008390-200510000-00001.

    PubMed 16179860

  • Serrone L, Zeuli M, Sega FM, Cognetti F. Dacarbazine-based chemotherapy for metastatic melanoma: thirty-year experience overview. J Exp Clin Cancer Res. 2000 Mar;19(1):21-34.

    PubMed 10840932

  • Huncharek M, Caubet JF, McGarry R. Single-agent DTIC versus combination chemotherapy with or without immunotherapy in metastatic melanoma: a meta-analysis of 3273 patients from 20 randomized trials. Melanoma Res. 2001 Feb;11(1):75-81. doi: 10.1097/00008390-200102000-00009.

    PubMed 11254118

  • Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745-51. doi: 10.1200/JCO.1999.17.9.2745.

    PubMed 10561349

  • Ernsdorf MS, C.T., and L Titus-Ernsdorf. 2003. Update: Medical therapy for cutaneous melanoma. ASCO Educational Book 39:198-207.

  • Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, Abrams J, Sznol M, Parkinson D, Hawkins M, Paradise C, Kunkel L, Rosenberg SA. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul;17(7):2105-16. doi: 10.1200/JCO.1999.17.7.2105.

    PubMed 10561265

  • Morton DL, Eilber FR, Joseph WL, Wood WC, Trahan E, Ketcham AS. Immunological factors in human sarcomas and melanomas: a rational basis for immunotherapy. Ann Surg. 1970 Oct;172(4):740-9. doi: 10.1097/00000658-197010000-00018. No abstract available.

    PubMed 5272336

  • Golub SH, Morton DL. Sensitisation of lymphocytes in vitro against human melanoma-associated antigens. Nature. 1974 Sep 13;251(5471):161-3. doi: 10.1038/251161a0. No abstract available.

    PubMed 4421563

  • Waldmann TA. Effective cancer therapy through immunomodulation. Annu Rev Med. 2006;57:65-81. doi: 10.1146/annurev.med.56.082103.104549.

    PubMed 16409137

  • Kawakami Y, Eliyahu S, Jennings C, Sakaguchi K, Kang X, Southwood S, Robbins PF, Sette A, Appella E, Rosenberg SA. Recognition of multiple epitopes in the human melanoma antigen gp100 by tumor-infiltrating T lymphocytes associated with in vivo tumor regression. J Immunol. 1995 Apr 15;154(8):3961-8.

    PubMed 7706734

  • Kawakami Y, Robbins PF, Wang RF, Parkhurst M, Kang X, Rosenberg SA. The use of melanosomal proteins in the immunotherapy of melanoma. J Immunother. 1998 Jul;21(4):237-46. doi: 10.1097/00002371-199807000-00001.

    PubMed 9672845

  • van der Bruggen P, Traversari C, Chomez P, Lurquin C, De Plaen E, Van den Eynde B, Knuth A, Boon T. A gene encoding an antigen recognized by cytolytic T lymphocytes on a human melanoma. Science. 1991 Dec 13;254(5038):1643-7. doi: 10.1126/science.1840703.

    PubMed 1840703

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cyclophosphamide and Mature dendritic cell vaccine in people with Melanoma, run by University of Pennsylvania at 1 site 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?

The sponsor lists 12 inclusion and 10 exclusion criteria. 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 29 Jun 2025. 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 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 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.

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?

Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay. (time frame: Through completion of treatment). The study lists 2 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 NCT00683670, which also lists 53 linked publications.

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 29 Jun 2025.

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