Know Cancer

or
forgot password

Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Glioblastoma, Brain Tumor

Thank you

Trial Information

Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma


Inclusion Criteria:



- Accessible volume and quality of tumor tissue for vaccine production

- MRI after surgery with minimal tumor remnant.

- Between 18 and 70 years of age.

- Must have histologically confirmed glioma grade IV, and a candidate for combined
radiation therapy and chemotherapy ("Stupps regimen").

- Must be ambulatory with a ECOG performance status 0 or 1.

- A minimum 4 weeks must have elapsed between the end of glucocorticoid treatment and
beginning of vaccination.

- Signed informed consent and expected cooperation of the patients for the treatment
and follow up must be obtained and documented.

Exclusion Criteria:

- Tumor in a localization where a modest increase in size due to reactive oedema may
have a large impact on patients neurological condition.

- Large tumor remnant after surgery.

- History of prior malignancy other than glioma, with the exception of curatively
treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.

- Chronic active infection requiring antibiotic therapy.

- Significant cardiac or other medical illness that would limit activity or survival,
such as severe congestive heart failure, unstable angina, or serious cardiac
arrhythmia.

- Prior splenectomy.

- Glucocorticoid treatment not possible to terminate due to autoimmune disease or
increased intracranial pressure.

- Adverse reactions to vaccines such as asthma, 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.

- Chemotherapy or other potentially immune-suppressive therapy that has been
administered within 4 weeks prior to vaccination.

- Pregnancy or lactation.

- Any reason why, in the opinion of the investigator, the patient should not
participate.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Outcome Time Frame:

During follow-up

Safety Issue:

Yes

Principal Investigator

Steinar Aamdal, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Cancer Research, Rikshospitalet

Authority:

Norway: Norwegian Medicines Agency

Study ID:

DC-CAST-GBM

NCT ID:

NCT00846456

Start Date:

January 2009

Completion Date:

October 2015

Related Keywords:

  • Glioblastoma
  • Brain Tumor
  • Tumor setm cell
  • Brain Neoplasms
  • Glioblastoma

Name

Location