Know Cancer

or
forgot password

A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Glioma, Anaplastic Astrocytoma, Anaplastic Astro-oligodendroglioma, Glioblastoma

Thank you

Trial Information

A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma

Inclusion Criteria


PATIENT ELIGIBILITY

Inclusion Criteria

1. Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic
astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)}
will be eligible for this protocol.

2. Patients must have had surgical resection at UCLA (University of California, Los
Angeles), for which a separate informed consent was signed for the collection of
their tumor prior to surgery.

3. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV)
will need to be established.

4. Patients must be 18 years or older and able to read and understand the informed
consent document. Patients must sign the informed consent indicating that they are
aware of the investigational nature of this study.

5. Patients must have a Karnofsky performance status (KPS) rating of > 60 prior to
initiating treatment. Patients may be enrolled at a KPS of < 60 if it is felt that
the patient will have adequate opportunity to recover to a KPS of > 60 by the
initiation of treatment.

Exclusion Criteria

1. Subjects with an active infection.

2. Inability to obtain informed consent because of psychiatric or complicating medical
problems.

3. Unstable or severe intercurrent medical or psychiatric conditions as determined by
the Investigator.

4. Females of child-bearing potential who are pregnant or lactating or who are not using
approved contraception.

5. History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid
arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis,
scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that
may be exacerbated by immunotherapy.

6. Subjects with organ allografts.

7. Inability or unwillingness to return for required visits and follow-up exams.

8. Subjects who have an uncontrolled systemic malignancy that is not in remission.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Most effective combination of DC vaccine components

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

10-000202

NCT ID:

NCT01204684

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Glioma
  • Anaplastic Astrocytoma
  • Anaplastic Astro-oligodendroglioma
  • Glioblastoma
  • dendritic cells
  • glioma
  • vaccine
  • glioma of WHO Grade III or IV
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma

Name

Location

University of Los Angeles, CaliforniaLos Angeles, California  90095