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Immunotherapy for Recurrent Ependymomas in Children Treatment for Recurrent Ependymomas Using HLA-A2 Restricted Tumor Antigen Peptides in Combination With Imiquimod


N/A
12 Months
21 Years
Open (Enrolling)
Both
Recurrent Ependymoma

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Trial Information

Immunotherapy for Recurrent Ependymomas in Children Treatment for Recurrent Ependymomas Using HLA-A2 Restricted Tumor Antigen Peptides in Combination With Imiquimod


Inclusion Criteria:

All grades of ependymoma are eligible.

- HLA-A2 positive based on flow cytometry performed at the University of Pittsburgh.

- Patients must have previously received standard initial therapy including attempted
gross total resection, where safely feasible, and in appropriate circumstances (e.g.,
those older than one year at initial diagnosis, with non-metastatic tumors and at
least microscopic residual disease), involved field fractionated radiation therapy
(RT) with total doses of 5000 to 6000 cGy.

●Patients must be clinically stable and off or on low ¬dose (no more than 0.1
mg/kg/day, max 4 mg/day Dexam¬ethasone) corticosteroid for at least one week prior to
study registration.

- Patients must be ≥ 12 months and <22 years of age at the time of study registration.

- Patients must have a performance status of > 70; (Karnofsky if > 16 years and Lansky
if < 16 years of age).

- Patients may have non-bulky, asymptomatic metastatic disease.

- Patients must have a life expectancy of at least 8 weeks.

- Patients must be free of systemic infection at the time of registration and off IV
antibiotics for at least 7 days prior to registration.

- Patients must have adequate organ function as measured by:

- Bone marrow: ANC > 1,000/µl; Platelets > 100,000/µl (transfusion independent);
ALC ≥ 500/µl; Hemoglobin >8 g/dl (may be transfused).

- Hepatic: bilirubin ≤ 1.5x institutional normal for age; SGPT (ALT) < 3x
institutional normal

- Renal: Serum creatinine based on age or creatinine clearance or radioisotope GFR
> 70 ml/min/1.73 m²

- Patients must have recovered from the toxic effects of prior therapy and be
at least 3 weeks from the last dose of standard cytotoxic chemotherapy or
myelosuppressive biological therapy, at least one week from the last dose
of non-myelosuppressive biological therapy and at least 3 months from the
completion of radiation therapy.

- Patients must have no overt cardiac, gastrointestinal, pulmonary, or
psychiatric disease.

Patients must be willing to travel to Pittsburgh to receive the vaccine. Visits: Every 3
weeks x 8, then every 6 weeks x 12 depending on response/side effects

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Participants with unacceptable toxicity

Outcome Description:

Grade 3 or 4 non-hematological toxicities.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Regina I Jakacki, MD

Investigator Role:

Principal Investigator

Authority:

United States: Food and Drug Administration

Study ID:

PRO12050422

NCT ID:

NCT01795313

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Recurrent Ependymoma
  • Ependymoma

Name

Location

Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213