A Phase I Trial Combining Triapine with Radiation Therapy for Recurrent Glioblastoma - SCHEMA

Aug 30, 2026

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SCHEMA protocol for NCI-supported Phase I evaluation of combining Triapine with radiation therapy in patients with recurrent glioblastoma. The document specifies key identifiers, participating organizations, and investigators, and defines study objectives including primary and secondary endpoints. It outlines eligibility and exclusion criteria, registration and patient enrollment procedures, and detailed biomarker/correlative research logistics such as specimen collection, shipping, and tracking. It further covers treatment planning, dosing delays and modifications, dose-limiting toxicity definitions, supportive care guidance, pharmaceutical information, statistical considerations, and adverse event reporting requirements.

LanguageEnglish

CategoryForms

FormatDOCX

Pages103

Reading Time36 min

AccessFree to download

OBJECTIVES

Primary Objectives

Secondary Objectives

BACKGROUND

Study Disease(s)

CTEP IND Agent (Triapine)

PATIENT SELECTION

Eligibility Criteria

Exclusion Criteria

NCI Protocol #: 10699 Local Protocol #: PhI-151 ClinicalTrials.gov Identifier: TBD TITLE: A Phase I Trial Combining Triapine with Radiation Therapy for Recurrent Glioblastoma Corresponding Organization: LAO-CA043 / City of Hope Comprehensive Cancer Center LAO Principal Investigator: Stephanie Yoon, M.D. City of Hope Cancer Center Department of Radiation Oncology 1500 E Duarte Road Duarte, CA, 91010, USA Phone: 626-218-2276 Fax: 626-218-5334 HYPERLINK "mailto:styoon@coh.org" styoon@coh.org Translational PI: Terence Williams, M.D., Ph.D. City of Hope Cancer Center Department of Radiation Oncology 1500 E Duarte Road Duarte, CA, 91010, USA Phone: 626-218-2276 Fax: 626-218-5334 HYPERLINK "mailto:terwilliams@coh.org" terwilliams@coh.org Participating Organizations Statistician: Study Coordinator: Joycelynne Palmer, Ph.D. Stella Khoo, MBA Division of Biostatistics City of Hope 1500 E Duarte Road 1500 E. Duarte Road Duarte, CA, USA, 91010 Duarte, CA, USA 91010 626-218-5266 626-218-0094 HYPERLINK "mailto:jmpalmer@coh.org" jmpalmer@coh.org HYPERLINK "mailto:ccc@coh.org" ccc@coh.org NCI-Supplied Agent: Triapine (NSC 663249) IND #: TBD IND Sponsor: NCI DCTD Protocol Type / Version # / Version Date: Original / September 20, 2024 SCHEMA TABLE OF CONTENTS TOC \o "1-2" \h \z \u HYPERLINK \l "_Toc176419885" SCHEMA PAGEREF _Toc176419885 \h 3 HYPERLINK \l "_Toc176419886" 1. OBJECTIVES PAGEREF _Toc176419886 \h 6 HYPERLINK \l "_Toc176419887" 1.1 Primary Objectives PAGEREF _Toc176419887 \h 6 HYPERLINK \l "_Toc176419888" 1.2 Secondary Objectives PAGEREF _Toc176419888 \h 6 HYPERLINK \l "_Toc176419889" 2. BACKGROUND PAGEREF _Toc176419889 \h 6 HYPERLINK \l "_Toc176419890" 2.1 Study Disease(s) PAGEREF _Toc176419890 \h 6 HYPERLINK \l "_Toc176419891" 2.2 CTEP IND Agent (Triapine) PAGEREF _Toc176419891 \h 7 HYPERLINK \l "_Toc176419892" 2.3 Rationale PAGEREF _Toc176419892 \h 10 HYPERLINK \l "_Toc176419893" 2.4 Correlative Studies Background PAGEREF _Toc176419893 \h 15 HYPERLINK \l "_Toc176419894" 3. PATIENT SELECTION PAGEREF _Toc176419894 \h 17 HYPERLINK \l "_Toc176419895" 3.1 Eligibility Criteria PAGEREF _Toc176419895 \h 17 HYPERLINK \l "_Toc176419896" 3.2 Exclusion Criteria PAGEREF _Toc176419896 \h 19 HYPERLINK \l "_Toc176419897" 3.3 Inclusion of Women and Minorities PAGEREF _Toc176419897 \h 20 HYPERLINK \l "_Toc176419898" 4. REGISTRATION PROCEDURES PAGEREF _Toc176419898 \h 20 HYPERLINK \l "_Toc176419899" 4.1 Investigator and Research Associate Registration with CTEP PAGEREF _Toc176419899 \h 20 HYPERLINK \l "_Toc176419900" 4.2 Site Registration PAGEREF _Toc176419900 \h 21 HYPERLINK \l "_Toc176419901" 4.3 Patient Registration PAGEREF _Toc176419901 \h 24 HYPERLINK \l "_Toc176419902" 4.4 General Guidelines PAGEREF _Toc176419902 \h 26 HYPERLINK \l "_Toc176419903" 5. BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES PAGEREF _Toc176419903 \h 27 HYPERLINK \l "_Toc176419904" 5.1 Summary Table for Specimen Collection PAGEREF _Toc176419904 \h 27 HYPERLINK \l "_Toc176419905" 5.2 Summary Table(s) for Interventional Radiologist for Research Biopsies PAGEREF _Toc176419905 \h 28 HYPERLINK \l "_Toc176419906" 5.3 Specimen Procurement Kits and Scheduling PAGEREF _Toc176419906 \h 28 HYPERLINK \l "_Toc176419907" 5.4 Specimen Tracking System Instructions PAGEREF _Toc176419907 \h 29 HYPERLINK \l "_Toc176419908" 5.5 Specimen Collection PAGEREF _Toc176419908 \h 34 HYPERLINK \l "_Toc176419909" 5.6 Shipping Specimens from Clinical Site to the EET Biobank PAGEREF _Toc176419909 \h 37 HYPERLINK \l "_Toc176419910" 5.7 Shipping of Specimens from Clinical Site to Other Laboratories PAGEREF _Toc176419910 \h 39 HYPERLINK \l "_Toc176419911" 5.8 Biomarker Plan PAGEREF _Toc176419911 \h 40 HYPERLINK \l "_Toc176419912" 5.9 Integrated Correlative St

FAQs

What is the study’s main purpose in this SCHEMA protocol?

The protocol evaluates a Phase I combination of Triapine with radiation therapy for recurrent glioblastoma, with primary and secondary objectives to define clinical outcomes and related measures.

Who are the key roles and participating organizations listed in the protocol?

The protocol identifies principal and translational investigators at City of Hope Comprehensive Cancer Center and lists participating organization roles including study coordinator and statistician.

What sections describe patient eligibility and study workflow?

Patient selection includes eligibility and exclusion criteria, and registration procedures cover investigator/site registration and patient registration steps.

Aug 30, 2026

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