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A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Gliomas, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Glioma, Glioblastoma Multiforme, Malignant Meningioma

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Trial Information

A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas

Inclusion Criteria


INCLUSION CRITERIA

To participate in this clinical trial, patients must meet the following eligibility
criteria:

1. Subjects must have a histologically proven diagnosis of malignant glioma or
meningioma and been treated with prior standard radiation and chemotherapy. There
must be evidence of unequivocal progression by MRI.

2. Tumor must be amenable to resection, and surgical resection must be clinically
indicated.

3. Age at least 18 years.

4. Karnofsky performance scale score >60.

5. Adequate hematologic function: a) systemic white blood cell count greater than 2 x
103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%.

6. Adequate renal function, with creatinine less than two times the upper limit.

7. Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin < 2x
upper limit of normal.

8. Patients must have an expected survival of at least three months.

9. Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.

10. Patients must sign an informed consent.

EXCLUSION CRITERIA

Patients will be excluded from the trial if the patients:

1. have multifocal tumors, bihemispheric tumors, infratentorial tumors, or
non-surgically accessible tumors.

2. have prior tumor resections where the ventricles were extensively breached.

3. are pregnant or breast-feeding women.

4. are females of child-bearing potential unable or unwilling to practice adequate birth
control methods.

5. have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments,
cerebral aneurysm clips, pacemaker).

6. have concurrent malignancy, excluding curatively treated basal or squamous cell
carcinoma of the skin, or carcinoma in situ of the cervix.

7. have concurrent systemic infection.

8. have any clinically significant, uncontrolled medical illness, as determined by the
investigators.

9. are unwilling or unable to comply with procedures required in this protocol.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients with adverse events as a measure of safety and tolerability

Outcome Time Frame:

5 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

UCLA 07-09-008

NCT ID:

NCT01144247

Start Date:

July 2010

Completion Date:

July 2015

Related Keywords:

  • Gliomas
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Mixed Glioma
  • Glioblastoma Multiforme
  • Malignant Meningioma
  • Recurrent Grade III or Grade IV Gliomas
  • anaplastic astrocytoma
  • anaplastic oligodendroglioma
  • anaplastic mixed glioma
  • glioblastoma multiforme
  • biotherapy
  • malignant meningioma
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Meningioma
  • Oligodendroglioma

Name

Location

University of California, Los AngelesLos Angeles, California