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

Primary Purpose

Central Nervous System Tumors

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Radiotherapy

nedaplatin

vincristine

Temozolomide

About this trial

This is an interventional treatment trial for Central Nervous System Tumors focused on measuring Lymphoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Neurosurgery, Shandong Cancer Hospital and Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of complete radiologic response (CR)

final data collection date for primary outcome measure

Secondary Outcome Measures

Failure-free survival

Toxicity

Overall response rate

Full Information

NCT ID

NCT01735747

First Posted

November 23, 2012

Last Updated

March 11, 2013

Sponsor

Rongjie Tao

Collaborators

National Natural Science Foundation of China

1. Study Identification

Unique Protocol Identification Number

NCT01735747

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rongjie Tao

Collaborators

National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Tumors

Keywords

Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

WBRT (whole-brain radiotherapy), Concurrent Chemoradiotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

nedaplatin

Intervention Description

nedaplatin (80mg/m2 i.v., day 1), 28 day schedule, performed four weeks after radiotherapy.A maximum of six cycles were applied.

Intervention Type

Drug

Intervention Name(s)

vincristine

Other Intervention Name(s)

ao-xian-da

Intervention Description

vincristine (1.4mg/m2 i.v., day 1)28 day schedule,performed four weeks after radiotherapy.A maximum of six cycles were applied.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

Temozolomide (200mg/m2 orally, days 1-5, Each cycle was 4 weeks ), performed four weeks after radiotherapy. A maximum of six cycles were applied.

Primary Outcome Measure Information:

Title

Rate of complete radiologic response (CR)

Description

final data collection date for primary outcome measure

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Failure-free survival

Time Frame

3 years

Title

Toxicity

Time Frame

3 years

Title

Overall response rate

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-fang Zhu, M.D.

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yong Wang, M.M.

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Study Director

Facility Information:

Facility Name

Neurosurgery, Shandong Cancer Hospital and Institute

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250117

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

17325700

Citation

Reni M, Zaja F, Mason W, Perry J, Mazza E, Spina M, Bordonaro R, Ilariucci F, Faedi M, Corazzelli G, Manno P, Franceschi E, Pace A, Candela M, Abbadessa A, Stelitano C, Latte G, Ferreri AJ. Temozolomide as salvage treatment in primary brain lymphomas. Br J Cancer. 2007 Mar 26;96(6):864-7. doi: 10.1038/sj.bjc.6603660. Epub 2007 Feb 27.

Results Reference

background

PubMed Identifier

19841864

Citation

Kurzwelly D, Glas M, Roth P, Weimann E, Lohner H, Waha A, Schabet M, Reifenberger G, Weller M, Herrlinger U. Primary CNS lymphoma in the elderly: temozolomide therapy and MGMT status. J Neurooncol. 2010 May;97(3):389-92. doi: 10.1007/s11060-009-0032-0. Epub 2009 Oct 20.

Results Reference

background

PubMed Identifier

12488408

Citation

DeAngelis LM, Seiferheld W, Schold SC, Fisher B, Schultz CJ; Radiation Therapy Oncology Group Study 93-10. Combination chemotherapy and radiotherapy for primary central nervous system lymphoma: Radiation Therapy Oncology Group Study 93-10. J Clin Oncol. 2002 Dec 15;20(24):4643-8. doi: 10.1200/JCO.2002.11.013.

Results Reference

background

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

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