TerminatedPhase 1/2

Phase I/II Trial of AXL1717 in the Treatment of Recurrent Malignant Astrocytomas

Stopped: Investigator went to another institution.

United States10 participantsStarted 2012-12

Plain-language summary

This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days during cycle 5). The following cycle will not be started until the treatment continuation criteria are fulfilled. Concomitant supportive therapies will be allowed.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Be informed of the nature of the study and have provided written informed consent
✓. At least 18 years of age
✓. ECOG performance of 0, 1, or 2, or KPS (Karnofsky performance status) ≥ 60.
✓. Pathological verification of a WHO grade 4 astrocytoma (glioblastoma or gliosarcoma), or WHO Grade 3 anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic ependymoma.
✓. Documented recurrent glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic ependymoma after at least one failed treatment of chemotherapy and radiation
✓. Expected survival of at least 3 months
✓. At least 2-weeks from cytoreductive surgery, if performed, 4-weeks from bevacizumab or other chemotherapy (6-weeks if prior chemotherapy was nitrosourea) and 12-weeks from completion of radiotherapy.
✓. Ability to undergo MRI scanning without and with imaging dye on a periodic basis as defined in the protocol

Exclusion criteria

What they're measuring

Phase I - Determine Recommended Phase II Dose

Timeframe: 8 months

Phase II - To Determine if AXL1717 Has Any Antitumor Effect

Timeframe: 24 Weeks

Trial details

NCT IDNCT01721577

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

Results submitted2021-10-13

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