Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma

Conditions

• High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• nab-sirolimus — DRUG
  nab-sirolimus, single agent
• nab-sirolimus + temozolomide — DRUG
  temozolomide, combination
• nab-sirolimus + bevacizumab — DRUG
  bevacizumab, combination
• nab-sirolimus + lomustine — DRUG
  lomustine, combination
• nab-sirolimus + marizomib (MRZ) — DRUG
  marizomib (MRZ), combination
• nab-sirolimus + temozolomide + radiotherapy — DRUG
  temozolomide + radiotherapy, combination

Study Details

Phase 2, open-label study of nab-sirolimus in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies.

Key Dates

First listed

Mar 13, 2018

Start date

Aug 1, 2018

Status verified

Nov 2023

Primary completion

Aug 26, 2022

Completion

Aug 26, 2022

Study Design

Enrollment

62 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A, Cohort 1: nab-sirolimus in patients with recurrent high grade glioma
  nab-Sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin) was administered at 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle.
• Experimental: Arm A, Cohort 2: nab-sirolimus + temozolomide (TMZ) in patients with recurrent high grade glioma
  nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle). Temozolomide (PO at 50 mg/m2 daily)
• Experimental: Arm A, Cohort 3: nab-sirolimus + bevacizumab in patients with recurrent high grade glioma
  nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle). Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle).
• Experimental: Arm A, Cohort 4: nab-sirolimus + lomustine (CCNU) in patients with recurrent high grade glioma
  nab-Sirolimus was administered at 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. CCNU was administered PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks).
• Experimental: Arm A, Cohort 5: nab-sirolimus + marizomib (MRZ) in patients with recurrent high grade glioma
  nab-Sirolimus was administered at 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ was administered at 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ was administered approximately 10 minutes after the end of the nab-sirolimus infusion.
• Experimental: Arm B: nab-sirolimus + temozolomide + radiotherapy in patients with newly diagnosed glioblastoma
  Induction Treatment (4 weeks) with nab-sirolimus (60 mg/m2 IV weekly); followed by Concomitant Treatment (standard of care; 2 cycles): nab-sirolimus (60 mg/m2 IV on Days 8 and 15 of every 21-day cycle) in combination with TMZ (75 mg/m2 PO daily for 6 weeks) + radiotherapy (30 × 200 cGy, 5 days/week); followed by Adjuvant Treatment (6 cycles) starting 4 weeks after Concomitant Treatment, with nab-sirolimus(60 mg/m2 IV on Days 1, 8, and 15 of every 28-day cycle) in combination with TMZ (150 mg/m2 PO daily on Days 1-5 of every 28-day cycle)

Primary Outcome Measure

ORR [ Time Frame: Through study completion (up to 48 months) ]

Locations (3)

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