Clinical Trial: Study of Suberoylanilide Hydroxamic Acid (SAHA) With Temsirolimus in Children With Diffuse Intrinsic Pontine Glioma (DIPG)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) With Temsirolimus in Children With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma (D

Brief Summary: The goal of this clinical research study is to learn the highest tolerable dose of temsirolimus that can be combined with a stable dose of vorinostat and/or radiation therapy and given to patients with diffuse intrinsic pontine glioma (DIPG). The safety of this treatment combination will also be studied.

Detailed Summary:

Study Groups:

If participant is found to be eligible to take part in this study, participant will be in 1 of 2 study groups based on when participant was diagnosed with DIPG:

  • If participant is newly diagnosed with DIPG, participant will be in Group 1. Participant will receive radiation therapy and vorinostat, then the combination of vorinostat and temsirolimus.
  • If participant has been diagnosed with DIPG before and the disease has gotten worse since, participant will be in Group 2. Participant will receive the combination of vorinostat and temsirolimus without receiving radiation therapy.

Study Drug Administration:

Participant will be assigned to a dose level of temsirolimus based on when participant joined this study. Up to 2 dose levels of temsirolimus will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. The second group will receive a higher dose than the group before it, if no intolerable side effects were seen.

All participants will receive the same dose level of vorinostat, though the dose may be lowered if there are intolerable side effects.

Vorinostat should be taken with food. Participant should be careful not to open or break the capsules of vorinostat. If a capsule breaks, participant should try to clean it up carefully without breathing in any of the powder. Participant should wash the spill area at least 3 times with ethyl alcohol, and then rinse it 1 time with water. If the powder comes in contact with participant's skin, participant should wash the aff
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Maximum Tolerated Dose (MTD) of Temsirolimus with Vorinostat [ Time Frame: 28 days ]

MTD defined as the highest dose studied in which six patients have been treated and at most two patients with dose-limiting toxicities (DLTs) are observed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Response Rate of Vorinostat and Temsirolimus [ Time Frame: After 3, 28 day cycles ]

Complete Response (CR) defined as no evidence of disease at primary tumor site. Partial Response (PR) defined as a greater than 50% reduction in the product of greatest tumor diameter and its perpendicular diameter on MRI scan.

Minor Response (MR) defined as a greater than or equal to 25% but less than or equal to 50% reduction in the product of greatest tumor diameter and its perpendicular diameter on MRI scan.

Stable Disease (SD) defined as a less than 25% reduction in the product of the greatest tumor diameter and its perpendicular diameter on MRI scan, Progressive Disease (PD) defined as a more than 25% increase in tumor size radiographically or the emergence of new lesions or CSF positivity or evidence of clinical progression.

Response Evaluation Criteria in Solid Tumors (RECIST) used from the NCI for assessment of radiographic response.



Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 15, 2015
Date Started: October 2015
Date Completion: October 2018
Last Updated: February 20, 2017
Last Verified: February 2017