Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Logistical problems)
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00961844
First received: August 12, 2009
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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 Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of immunological responses, time to disease progression and survival time. [ Time Frame: 5 years of follow-up. ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 12, 2009
Last Updated: August 22, 2014
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014