Know Cancer

forgot password

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

Phase 2
18 Years
70 Years
Open (Enrolling)
Primary Central Nervous System Lymphoma

Thank you

Trial Information

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

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.

Inclusion Criteria:

- Histologically proven primary CNS lymphoma.

- Absence of disease outside the CNS.

- ECOG performance status 0-3

- Negative HIV status.

- Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L.
Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit
of normal.

- Age >18 and <=70 years.

- Patients must give written informed consent.

- Corticosteroids prior to histological diagnosis are allowed.

Exclusion Criteria:

- Previous history of malignancy (other than non-melanomatous skin carcinoma, or
carcinoma in situ of cervix completely excised).

- Patients who are pregnant or lactating.

- NYHA (New York State Heart Association classification) cardiac failure grade 3

- Macroscopic spinal thecal or spinal cord disease.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the median and 2 year overall survival.

Outcome Time Frame:

Estimate of survival at 2 years and at 5 years.

Safety Issue:


Principal Investigator

Peter O'Brien, FRANZCR

Investigator Role:

Study Chair

Investigator Affiliation:

Newcastle Mater Misericordiae Hospital


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 01.02



Start Date:

July 2001

Completion Date:

July 2009

Related Keywords:

  • Primary Central Nervous System Lymphoma
  • Lymphoma
  • Primary CNS lymphoma
  • Lymphoma