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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: June 10, 2004
Last updated: January 30, 2015
Last verified: October 2005

RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.

Condition Intervention Phase
Melanoma (Skin) Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma [ Time Frame: 2005-2006 ]

Study Start Date: February 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma.
  • Determine the safety and tolerability of this therapy in these patients.


  • Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy.

OUTLINE: This is a dose-escalation, pilot study.

Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56.

Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity.

Patients are followed at day 84 and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed melanoma

    • Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease
  • Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease)
  • Tumor tissue available and properly stored for lysate preparation



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3


  • AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
  • Bilirubin ≤ 2 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C negative


  • Creatinine ≤ 2.0 times ULN


  • No active infection
  • No history of autoimmune disease, including any of the following:

    • Inflammatory bowel disease
    • Systemic lupus erythematosus
    • Scleroderma
    • Rheumatoid arthritis
    • Multiple sclerosis
  • No allergy to aminoglycosides or streptomycin
  • HIV negative


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant comorbid illness
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix


Biologic therapy

  • See Disease Characteristics
  • At least 10 days since prior immunotherapy


  • See Disease Characteristics

Endocrine therapy

  • At least 6 weeks since prior steroid therapy
  • No concurrent corticosteroids


  • At least 10 days since prior radiotherapy
  • No concurrent radiotherapy


  • At least 10 days since prior surgery
  • Prior diagnostic or palliative surgery allowed provided the patient has fully recovered


  • No concurrent immunosuppressive or potentially immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00085488

United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Study Chair: Christopher P. Tretter, MD Norris Cotton Cancer Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00085488     History of Changes
Other Study ID Numbers: CDR0000370802
Study First Received: June 10, 2004
Last Updated: January 30, 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:
recurrent melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs processed this record on July 21, 2017