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A Phase IIA Study of the Addition of Temozolomide to a Standard Conditioning Regimen for Autologous Stem Cell Transplantation in Relapsed and Refractory Central Nervous System (CNS) Lymphoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
B-Cell Lymphoma Originating in the CNS

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Trial Information

A Phase IIA Study of the Addition of Temozolomide to a Standard Conditioning Regimen for Autologous Stem Cell Transplantation in Relapsed and Refractory Central Nervous System (CNS) Lymphoma


Inclusion Criteria:



- Patients ≥ 18 years of age and ≤ 75 years of age

- A mature B-cell lymphoma originating in the CNS, (WHO criteria)

- Patients with relapsed or progressed disease following therapy for CNS B Cell
lymphoma who has achieved a subsequent CR or PR following salvage chemotherapy

- Patients who are initially refractory to therapy for CNS B cell lymphoma but who have
achieved a CR or PR following a salvage chemotherapy regimen

- Patients who have developed CNS B cell CNS lymphoma in the setting of systemic
disease as well. Provided there is limited systemic disease, such patients would be
eligible

- Patients fit for autologous stem cell transplantation

- Patients able to understand and willing to sign a written informed consent document

Exclusion Criteria:

- Patients with CNS B-cell lymphoma in remission status post primary, initial therapy

- Patients initially enrolled at relapse but who were not responsive to induction
therapy will not be continued on the study

- Patients whose life expectancy is severely limited by diseases other than malignancy

- Karnofsky Performance Score <60

- Patients who are pregnant or breastfeeding

- Patients who are HIV seropositive

- Patients who have an uncontrolled infection (presumed or documented) with progression
after appropriate therapy for greater than one month

- Patients with symptomatic coronary artery disease, uncontrolled congestive heart
failure. Left Ventricular Ejection Fraction is not required to be measured, however
if it is measured, patient is excluded if ejection fraction is <30%

- Patients requiring supplementary continuous oxygen. DLCO is not required to be
measured, however if it is measured, patient is excluded if DLCO <35%

- Patients with clinical or laboratory evidence of liver disease will be evaluated for
the cause of liver disease, its clinical severity in terms of liver function and
histology, and for the degree of portal hypertension. Patients with any of the
following liver function abnormalities will be excluded

1. Fulminant liver failure

2. Cirrhosis with evidence of portal hypertension or bridging fibrosis

3. Alcoholic hepatitis

4. Esophageal varices

5. A history of bleeding esophageal varices

6. Hepatic encephalopathy

7. Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the
prothrombin time

8. Ascites related to portal hypertension

9. Chronic viral hepatitis with total serum bilirubin >3 mg/dL ____mg/dL

10. Symptomatic biliary disease

- Patients with non-B-cell lymphomas or brain tumors that are not lymphomas are
Excluded from the study. Non-B-cell lymphomas include: any T-cell lymphoma, NK-cell
lymphomas, and Hodgkin lymphomas

- Patients for whom an insufficient number of stem cells (<2 X 106/kg) have been
collected

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy of the DRBEAT Regimen

Outcome Description:

Efficacy of the DRBEAT Regimen will be assessed by analysis of one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression, or death, and Overall survival, defined as the time interval between the date of transplant and the date of death from any cause.

Outcome Time Frame:

One Year

Safety Issue:

Yes

Principal Investigator

Amir Steinberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

Pro00019873

NCT ID:

NCT01235793

Start Date:

September 2010

Completion Date:

December 2013

Related Keywords:

  • B-Cell Lymphoma Originating in the CNS
  • Relapsed
  • Refractory
  • Primary Central Nervous System B-cell Lymphoma
  • Autologous Stem Cell Transplant
  • Temozolomide
  • B-Cell Lymphoma
  • RBEAM
  • Conditioning Regimen
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804