Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme: Phase I

Conditions

• Malignant Gliomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
  200 mg/m\^2 by vein over 90 minutes once every 2 weeks on days 1 and 15.
• Lenalidomide — DRUG
  Given orally at escalating doses beginning 7.5 mg/day on Cycle 1 Days 1-21 and 10 mg/day on Cycle 2 Days 1-21.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination can help control malignant gliomas. Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to learn the effect of lenalidomide on tumor tissue in patients who need surgery for the disease.

Key Dates

Start date

Apr 29, 2008

Status verified

Nov 2018

Primary completion

Feb 28, 2014

Completion

Feb 28, 2014

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Irinotecan + Lenalidomide
  Irinotecan 200 mg/m\^2 intravenous once every 2 weeks on days 1 and 15; Lenalidomide orally 7.5 mg/day on Cycle 1 Days 1-21 and 10 mg/day on Cycle 2 Days 1-21.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Lenalidomide and Irinotecan [ Time Frame: First cycle (28 days) ]

Locations (1)

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