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Protocol # 16-517

Status

Active, not recruiting

Description

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Condition

  • Anaplastic Astrocytoma
  • Recurrent Anaplastic Astrocytoma

Interventions

  • Eflornithine
  • Lomustine
  • Lomustine

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall survival

Secondary Outcome:

  • Progression-free survival (PFS)
  • Objective response rate (ORR)

Enrollment

343

Study Start Date

July 2016

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Orbus Therapeutics, Inc.

Source

Orbus Therapeutics, Inc.

Official title

A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Clinicaltrials.gov Identifier

NCT02796261

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.