Clinical Trial: Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma

Brief Summary: Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.

Detailed Summary:

Combined modality therapy in PCNSL has improved survival outcomes but at the cost of unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has activity in systemic lymphomas and crosses the blood brain barrier and may add to the efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy survival outcomes should be optimal but with lower rates of neurotoxicity.

Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose radiotherapy and this will allow comparison of survival and neurotoxicity rates.


Sponsor: Trans-Tasman Radiation Oncology Group (TROG)

Current Primary Outcome: To estimate the median and 2 year overall survival. [ Time Frame: Estimate of survival at 2 years and at 5 years. ]

Original Primary Outcome:

  • To estimate the median and 2 year overall survival.
  • To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.


Current Secondary Outcome:

  • Assess acute toxicity. [ Time Frame: Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients. ]
  • Assess functional indices of living in patients with PCNSL. [ Time Frame: Analysis will be at 5 years. ]
  • To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. [ Time Frame: Analysis at 3 years. ]


Original Secondary Outcome:

  • Assess acute toxicity.
  • Assess functional indices of living in patients with PCNSL.


Information By: Trans-Tasman Radiation Oncology Group (TROG)

Dates:
Date Received: September 13, 2005
Date Started: July 2001
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017