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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00085488
First received: June 10, 2004
Last updated: February 6, 2009
Last verified: October 2005
  Purpose

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 National Cancer Institute (NCI):

Study Start Date: February 2004
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 12 weeks

Hematopoietic

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

Hepatic

  • 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

Renal

  • Creatinine ≤ 2.0 times ULN

Immunologic

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

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

Radiotherapy

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

Surgery

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

Other

  • No concurrent immunosuppressive or potentially immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085488

Locations
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Norris Cotton Cancer Center
Investigators
Study Chair: Christopher P.G. Tretter, MD Norris Cotton Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00085488     History of Changes
Other Study ID Numbers: CDR0000370802, DMS-9935, DMS-14862
Study First Received: June 10, 2004
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 21, 2014