Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Rongjie Tao, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01735747
First received: November 23, 2012
Last updated: March 11, 2013
Last verified: March 2013

November 23, 2012
March 11, 2013
June 2008
November 2013   (final data collection date for primary outcome measure)
Rate of complete radiologic response (CR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
final data collection date for primary outcome measure
Same as current
Complete list of historical versions of study NCT01735747 on ClinicalTrials.gov Archive Site
  • Failure-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Overall response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma
Phase Ⅱ Trial of Temozolomide Plus Concurrent Whole-Brain Radiation Followed by TNV Regimen as Adjuvant Therapy for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PCNSL)

In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin, vincristine (TNV) as the replacement of high-dose methotrexate to combine with concurrent chemoradiotherapy. Our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.

The best reported outcomes of PCNSL treatment are high-dose methotrexate-based chemotherapy combined with whole-brain radiation therapy (WBRT). Despite aggressive therapy, however, nearly 50% of patients will relapse within 24 months of diagnosis. Furthermore, the application of high-dose methotrexate-based regimen is complex, needing be hydrated, alkalified and detoxified, and treatment-related toxicity mortality is severe[3,4]. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 PCNSL patients with temozolomide concurrent chemoradiotherapy at the outset and then adjuvant chemotherapy for 6 cycles with temozolomide, nedaplatin, vincristine, as part of front-line therapy. Our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Central Nervous System Tumors
  • Radiation: Radiotherapy
    WBRT was given five times a week at 2 gray (Gy)/d until the whole brain radiotherapy dose reached 40 gray. The patients were given concurrent temozolomide (75mg/m2, orally) daily during radiotherapy until the end of radiotherapy.
    Other Names:
    • WBRT (whole-brain radiotherapy)
    • Concurrent Chemoradiotherapy
  • Drug: nedaplatin
    nedaplatin (80mg/m2 i.v., day 1), 28 day schedule, performed four weeks after radiotherapy.A maximum of six cycles were applied.
  • Drug: vincristine
    vincristine (1.4mg/m2 i.v., day 1)28 day schedule,performed four weeks after radiotherapy.A maximum of six cycles were applied.
    Other Name: ao-xian-da
  • Drug: Temozolomide
    Temozolomide (200mg/m2 orally, days 1-5, Each cycle was 4 weeks ), performed four weeks after radiotherapy. A maximum of six cycles were applied.
Experimental: Temozolomide, Nedaplatin, Vincristine, Radiotherapy
The newly diagnosed PCNSL patients will be given concurrent temozolomide (75mg/m2, orally) daily during WBRT. Then, the TNV regimen will be given after four weeks. TNV regimen consisted of temozolomide (200mg/m2 orally, days 1-5), nedaplatin (80mg/m2 i.v., day 1), vincristine (1.4mg/m2 i.v., day 1). Each cycle was 4 weeks and a maximum of six cycles were applied.
Interventions:
  • Radiation: Radiotherapy
  • Drug: nedaplatin
  • Drug: vincristine
  • Drug: Temozolomide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed primary CNS lymphoma.
  • Newly diagnosed.
  • ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
  • Relevant hospital examination including laboratory examination and physical examination (Chest X-ray, electrocardiogram, abdomen B ultrasonography, magnetic resonance imaging (MRI) of head and neck) must to be done, in order to exclude other system fatal diseases.
  • Must have adequate organ function as defined by the protocol: Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl.
  • Age >/= 18 and </= 75 years
  • Signed written informed consent prior to study entry.

Exclusion Criteria:

  • Patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation.
  • Serious uncontrolled concurrent illness.
  • Previous brain radiotherapy, systemic chemotherapy.
  • Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol.
  • Any evidence of prior exposure to Hepatitis B virus.
  • Unable to comprehend the study requirements or who are not likely to comply with the study parameters.
  • Pregnant (confirmed by serum or urine β-HCG) or lactating.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01735747
ShandongCHI 002
Yes
Rongjie Tao, Shandong Cancer Hospital and Institute
Rongjie Tao
National Natural Science Foundation of China
Study Director: Yu-fang Zhu, M.D. Shandong Cancer Hospital and Institute
Study Director: Yong Wang, M.M. Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP