Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
SignPath Pharma, Inc.
Study ID
NCT05768919
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Treatment Period 1 — DRUG
    Agent: LipoCurc Premedication/Precautions: Dexamethasone 4mg IV, Diphenhydramine 25 mg IV - Dose: per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Weeks 1,2, 3,4,5,6 Cycle length: 6 weeks Agent: TMZ Premedications/Precautions No food 2 hr before and after dosing Antiemetic (eg, ondansetron, prochlorperazine) 30 minutes before dosing Stool softener PRN. Dose: 75 mg/m2 Route: Oral Schedule: Daily during term of RT Cycle Length: 6 weeks Agent: Radiotherapy Premedications/Precautions: n/a Dose: 2 Gy Route: External beam therapy Schedule: Monday-Friday Cycle Length 6 weeks
  • Treatment Period 2 — DRUG
    Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Weeks 7,8,9,10 Cycle length: 4 weeks
  • Treatment Period 3 — DRUG
    Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Adjuvant Cycles 11-34 Weeks 1, 2, 3, 4 of each cycle Cycle Length: 4 weeks Agent: TMZ Premedication/Precautions: No food 2 hr before and after dosing. Antiemetic (eg, ondansetron, prochlorperazine) 30 minutes before dosing Stool softener prn Dose: 150-200 mg/m2 (Cycles 1-6) Route: Oral Schedule: Daily Cycle Length: 4 weeks
  • Treatment Period 4a — DRUG
    Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: 35+ Weeks 1, 2, 3, 4 of each cycle Cycle Length: 4 weeks

Study Details

The objective of this study is to assess the tolerability, safety, and efficacy of Liposomal Curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) in patients with newly diagnosed High-Grade Gliomas (HGG).

Key Dates

Start date
Mar 3, 2023
Status verified
Nov 2024
Primary completion
Feb 28, 2026
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Tolerability, Safety, and Efficacy of LC in Combination with RT and TMZ
    Define the MTD/recommended Phase 2 dose (RP2D) of LC, administered IV weekly in combination with standard CRT (60 Gy in 30-33 fractions M-F, and daily oral TMZ 75 mg/m2), in patients with high grade malignant gliomas. This study seeks the MTD/RP2D of LC when added to TMZ during concurrent RT and adjuvant TMZ after RT. The study will evaluate escalating doses of LC delivered by IV infusion weekly as a gravity infusion (without infusion pump). Within each cohort, the dose will remain the same. In the first cohort, dosing will begin at Level 1 (300 mg/m2). The infusion of LC will begin at the start of CRT. Patients will be evaluable for the cohort if they have completed 80% of the planned doses of LC, 80% of RT and 60% of TMZ within the first 10 weeks of treatment. Patients who experience a dose-limiting toxicity (DLT) will be evaluable for the cohort if they have received at least 1 dose of LC.

Primary Outcome Measure

The number of observed Dose Limiting Toxicity (DLTs) [ Time Frame: 10 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Michelle Comas
[email protected]
801-557-1214
Solmaz Sahebjam, MD (SUB_INVESTIGATOR)
Michael J Pishvaian, MD, PhD (SUB_INVESTIGATOR)
Benjamin Levy, MD (SUB_INVESTIGATOR)
Rachel Alexander, MD (SUB_INVESTIGATOR)
Matthias Holdhoff, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University/Johns Hopkins HospitalBaltimoreMaryland21287
Matthias Holdhoff, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stuart Grossman, MD, PhD (SUB_INVESTIGATOR)
David Kamson, MD, PhD (SUB_INVESTIGATOR)
Jaishri Blakeley, MD, PhD (SUB_INVESTIGATOR)
Lawrence Kleinberg, MD, PhD (SUB_INVESTIGATOR)
John Laterra, MD, PhD (SUB_INVESTIGATOR)
Kristin Redmond, MD, PhD (SUB_INVESTIGATOR)
Karisa Schreck, MD, PhD (SUB_INVESTIGATOR)
Carlos Romo, MD, PhD (SUB_INVESTIGATOR)

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