A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas

NCT ID: NCT01130077

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2024-11-01

Brief Summary

The overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted.

Conditions

Newly Diagnosed Pediatric Pontine Glioma; Newly Diagnosed Pediatric High Grade Glioma; Recurrent Pediatric High Grade Glioma; Recurrent Pediatric Low Grade Glioma

Keywords

Pediatric glioma; Vaccine therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLA Restricted glioma antigen peptides plus Poly ICLC

All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

Group Type: EXPERIMENTAL

HLA-A2 restricted glioma antigen peptides vaccine

Intervention Type: BIOLOGICAL

Vaccine given every 3 weeks

Poly-ICLC

Intervention Type: BIOLOGICAL

Vaccine given every 3 weeks

Interventions

HLA-A2 restricted glioma antigen peptides vaccine

Vaccine given every 3 weeks

Intervention Type: BIOLOGICAL

Poly-ICLC

Vaccine given every 3 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

BB13624

Eligibility Criteria

Inclusion Criteria

*Tumor Types - Tumor type/location:

Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma* involving the brainstem. Patients may not have received chemotherapy during or after radiation. (Note: Stratum A is closed to accrual.)

Stratum B: Newly diagnosed, non-brainstem high-grade glioma* Patients may not have received chemotherapy during or after radiation. (Note: Stratum B is open to accrual.)

Stratum C: Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Patients may not have received radiation to the index lesion within 1 year of enrollment. (Note: Stratum C is closed to accrual.)

Stratum D: Non-brainstem high-grade gliomas* that have recurred following treatment. (Note: Stratum D is closed to accrual.)

Stratum E: Newly diagnosed high-grade gliomas* or brain stem gliomas who received chemotherapy during radiation therapy. Patients may not have received chemotherapy after radiation therapy was completed. (Note: Stratum E is closed to accrual.)

Stratum F: Newly diagnosed high-grade gliomas with metastatic disease within the CNS requiring craniospinal radiation therapy. Patients may or may not have received chemotherapy during radiation, but cannot have received chemotherapy after radiation therapy was completed. (Note: Stratum F is closed to accrual.)

• Eligible histologies include glioblastoma (GBM), anaplastic astrocytoma (AA) or gliosarcoma. Patients with any oligodendroglioma component are NOT eligible.
• HLA-A2 positive based on flow cytometry.
• Patients in Stratum A B and E must have received standard involved field radiation therapy [RT] defined as fractionated external beam radiotherapy with total doses between 5000-6000 cGy. Patients in these strata must be registered within 4-12 weeks of completing RT.
• Patients in Stratum F must have received craniospinal radiation.
• Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration.
• All patients must sign an IRB-approved informed consent document
• Patients must be ≥ 12 months and <22 years of age at the time of study registration.
• Patients must have a performance status of ≥ to 60.
• Patients must have life expectancy of at least 8 weeks.
• Documented negative serum βHCG for female patients who are post-menarchal. Pregnant females will not be included in the study. Males and females must agree to use effective birth control methods during the course of vaccination.
• Patients must be free of systemic infection.
• Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/µl; Platelets > 100,000/µl (transfusion independent); absolute lymphocyte count of ≥500/uL; 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/ml/min/1.73 m²

• Patients on Strata C and D must have recovered from the toxic effects of prior therapy: at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.
• No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

Exclusion Criteria

Patients living outside of North America are not eligible.

Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.

Patients in Stratum F must have tumor spread within the CNS.

Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.

Concurrent treatment or medications (must be off for at least 1 week) including:

• Interferon (e.g. Intron-A®)
• Allergy desensitization injections
• Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• Interleukins (e.g. Proleukin®)
• Any investigational therapeutic medication

Patients must not have a history of, or currently active autoimmune disorders.

Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration. Topical corticosteroids are acceptable.

Patients with known addiction to alcohol or illicit drugs.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ellie Kavalieros Fund

UNKNOWN

Sponsor Role: collaborator

Translational Brain Tumor Research Fund

UNKNOWN

Sponsor Role: collaborator

Connor's Cure

OTHER

Sponsor Role: collaborator

James Felker

OTHER

Sponsor Role: lead

Responsible Party

James Felker

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James Felker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Pollack IF, Jakacki RI, Butterfield LH, Hamilton RL, Panigrahy A, Potter DM, Connelly AK, Dibridge SA, Whiteside TL, Okada H. Antigen-specific immune responses and clinical outcome after vaccination with glioma-associated antigen peptides and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in children with newly diagnosed malignant brainstem and nonbrainstem gliomas. J Clin Oncol. 2014 Jul 1;32(19):2050-8. doi: 10.1200/JCO.2013.54.0526. Epub 2014 Jun 2.

Reference Type: DERIVED

PMID: 24888813 (View on PubMed)

Robison NJ, Kieran MW. Diffuse intrinsic pontine glioma: a reassessment. J Neurooncol. 2014 Aug;119(1):7-15. doi: 10.1007/s11060-014-1448-8. Epub 2014 May 3.

Reference Type: DERIVED

PMID: 24792486 (View on PubMed)

Other Identifiers

PRO08030085

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY19040319

Identifier Type: -

Identifier Source: org_study_id

NCT00862199

Identifier Type: -

Identifier Source: nct_alias