Is NCT02358187 recruiting in Pittsburgh, PA?

Yes, NCT02358187 is currently recruiting participants at its Pittsburgh, PA location. This low grade glioma clinical trial is actively enrolling qualified participants.

How do I join the low grade glioma clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Low Grade Glioma Clinical Trial in Pittsburgh, PA

About This Low Grade Glioma Study in Pittsburgh

The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)/tetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.

Sponsor: James Felker

Who Can Participate

Inclusion Criteria

Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may have tumor spread within the central nervous system (CNS).

HLA-A2 positive based on flow cytometry.

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.

Patients must be ≥ 12 months and \< 22 years of age at the time of HLA-A2 screening.

Patients must have a performance status of ≥ 70; (Karnofsky if \> 16 years and Lansky if ≤ 16 years of age.

Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal. Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not sufficiently been investigated, pregnant females will not be included in the study.

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

Patients with adequate organ function as measured by: Bone marrow: absolute neutrophil count (ANC) \> 1,000/µ; Platelets \> 100,000/µ (transfusion independent); absolute lymphocyte count of ≥ 500/µ; Hemoglobin \>8 g/dl (may be transfused). Hepatic: bilirubin \< 1.5x institutional normal for age; serum glutamate pyruvate transaminase (SGPT) \< 3x institutional normal.

Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml/min/ml/min/1.73 m²

Patients must have recovered from the toxic effects of prior therapy to grade 1 or better. Patients must be at least 3 weeks from 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.

Patients may not have received radiation to the index lesion within 1 year of enrollment.

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 requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.

Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to 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.

Because patients with immune deficiency are not expected to respond to this therapy, HIV-positive patients are excluded from the study.

Patients who have received prior immunotherapy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT02358187) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Low Grade Glioma Treatment Options in Pittsburgh, PA

If you're searching for low grade glioma treatment options in Pittsburgh, PA, this clinical trial (NCT02358187) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced low grade glioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all low grade glioma clinical trials near you to find additional studies recruiting in your area.

Low Grade Glioma Clinical Trial in Pittsburgh, PA

Expert Care in Pittsburgh

IRB Approved

No-Cost Care

Apply for This Pittsburgh Location

Why Participate?

Simple Process