hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Leland Metheny
Study ID
NCT05052957
Phase
PHASE2
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme, Adult
  • Supratentorial Glioblastoma
  • Supratentorial Gliosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • P140K-MGMT — BIOLOGICAL
    Ex Vivo Cultured P140K MGMT CD34+ Cells. The transduced cells are a biological product and production is detailed in the Cellular Therapy Lab standard operating procedures and IND 14099
  • O6-benzylguanine — DRUG
    O6BG is a low molecular-weight purine analog which selectively and irreversibly inactivates the DNA-repair enzyme, O6- alkylguanine DNA-alkyltransferase.
  • Photon Based Radiotherapy — RADIATION
    Standard of care, photon-based radiotherapy (60Gy in 30 fractions) will be performed in both arms without concomitant TMZ between to 6 weeks post-operatively. Radiotherapy will be performed at UH-SCC.
  • temozolomide — DRUG
    Temozolomide is not directly active but undergoes rapid non-enzymatic conversion at physiologic pHto the reactive compoundMTIC. The cytotoxicity of MTIC is thought to be primarily due to alkylationof DNA. Alkylation (methylation) occurs mainly at the O6 and N7 positions of guanine
  • Filgrastim — DRUG
    Filgrastim is a 175 amino acid protein manufactured by recombinant DNA technology. Endogenous filgrastim is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells, which regulates the production of neutrophils within the bone marrow.
  • carmustine — DRUG
    BCNU is a lipid soluble agent which has alkylating properties, plus an isocyanate metabolite which interferes with DNA and RNA synthesis.

Study Details

This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.

Key Dates

Start date
Jan 20, 2023
Status verified
Nov 2025
Primary completion
Jun 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: stem cell mobilization after radiation therapy
    Participants at University Hospitals-Seidman Cancer Center (UH-SCC) will receive stem cell mobilization after 6 weeks of standard of care (SOC) radiotherapy. Followed by SOC chemotherapy.

Primary Outcome Measure

Percent of participants able to complete treatment [ Time Frame: 10 years after start of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Leland Metheny, MD
[email protected]
216-844-0130

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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