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Trial for Vaccine Therapy With Dendritic Cells in Patients With Metastatic Malignant Melanoma

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ClinicalTrials.gov Identifier: NCT00961844
Recruitment Status : Terminated (Logistical problems)
First Posted : August 19, 2009
Last Update Posted : August 25, 2014
Sponsor:
Information provided by:
Oslo University Hospital

Brief Summary:
In this trial the investigators want to combine chemotherapy with immunotherapy by giving the patients Temozolomide, before vaccination. The investigators have also included hTERT and survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell expansion after lymphodepletion for the patients who show an immune response.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Melanoma Biological: Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion Drug: Temozolomide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial for Vaccine Therapy With Dendritic Cells - Transfected With hTERT-, Survivin- and Tumor Cell Derived mRNA + ex Vivo T Cell Expansion and Reinfusion in Patients With Metastatic Malignant Melanoma
Study Start Date : August 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: DC vaccine + Temozolomide
Dendritic cell loaded with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion.
Biological: Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion
Drug: Temozolomide



Primary Outcome Measures :
  1. Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.

Secondary Outcome Measures :
  1. Evaluation of immunological responses, time to disease progression and survival time. [ Time Frame: 5 years of follow-up. ]


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

Inclusion Criteria:

  • Histologically verified malignant melanoma with measurable (according to RECIST), unresectable metastases (Stage III or Stage IV M1a-c as defined by criteria of the AJCC Cancer Staging Manual, 6 th. Edition 2002). Patients with a melanoma of an unknown primary site are eligible.
  • Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA)
  • Must be at least 18 years of age
  • Must be ambulatory with a ECOG performance status 0 or 1
  • Life expectancy ≥ 6 months
  • Negative MRI of the brain
  • Must have lab values as the following:

    • ANC ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hb ≥ 9 g/dL (≥ 5.6 mmol/L)
    • Creatinine ≤ 140 μmol/L (1.6 mg/dL); if borderline, the creatinine clearance ≥ 40 mL/min
    • Bilirubin < 20% above the upper limit of normal
    • ASAT and ALAT ≤ 2.5 the upper limit of normal
    • Albumin ≥ 2.5 g/L
  • If the patient is female, she must practice adequate contraception during the study treatment
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations

Exclusion Criteria:

  • The patient suffers from an ocular- or mucous membrane melanoma
  • History of prior malignancy other than melanoma, except for curatively treated basal cell or squamous cell carcinoma of the skin and cervix cancer stage 1B or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
  • Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems. PI shall make the final determination regarding appropriateness of enrollment
  • Autoimmune disease currently being treated with systemic steroids Version no. 3, 18 June 2009 Page 17 of 50
  • Adverse reactions to vaccines such as anaphylaxis or other serious reactions
  • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome
  • Positive for HIV, Hepatitis B and C and Syphilis (treponema pallidum)
  • Pregnancy or lactation
  • If the patient has received any prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents, this must have been stopped at least 4 weeks before first study treatment administration.
  • Chemotherapy, glucocorticosteroids or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination
  • No treatment with dacarbazine or temozolomide at any time prior to study entry
  • Any reason why, in the opinion of the investigator, the patient should not participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961844


Locations
Norway
The Norwegian Radium Hospital, Department of Clinical Cancer Research
Oslo, Montebello, Norway, NO-0310
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Steinar Aamdal, M.D PhD Prof Oslo University Hospital - Norwegian Radium Hospital

Responsible Party: Steinar Aamdal, The Norwegian Radium Hospital, Division of Cancer Medicine and Radiotherapy
ClinicalTrials.gov Identifier: NCT00961844     History of Changes
Other Study ID Numbers: DC-004
2008-006253-41 ( EudraCT Number )
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

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
Vaccines
Temozolomide
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents