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

NCT01735747 | Unknown Phase 2 DMC

• 1 other identifier: ShandongCHI 002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Tumors

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of complete radiologic response (CR)

  final data collection date for primary outcome measure

  3 years

Secondary Outcomes (3)

• Failure-free survival

  3 years

• Toxicity

  3 years

• Overall response rate

  3 years

Study Arms (1)

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

EXPERIMENTAL

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.

Radiation: Radiotherapy; Drug: nedaplatin; Drug: vincristine; Drug: Temozolomide

Interventions

Radiotherapy RADIATION

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.

Also known as: WBRT (whole-brain radiotherapy), Concurrent Chemoradiotherapy

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

nedaplatin DRUG

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

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

vincristine DRUG

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

Also known as: ao-xian-da

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

Temozolomide DRUG

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

Temozolomide, Nedaplatin, Vincristine, Radiotherapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rongjie Tao: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Neurosurgery, Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

Related Publications (3)

• 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.

  PMID: 17325700 BACKGROUND

• 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.

  PMID: 19841864 BACKGROUND

• 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.

  PMID: 12488408 BACKGROUND

MeSH Terms

Conditions

Central Nervous System Neoplasms; Lymphoma

Interventions

Radiotherapy; Chemoradiotherapy; nedaplatin; Vincristine; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy; Drug Therapy; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Yu-fang Zhu, M.D.

  Shandong Cancer Hospital and Institute

  STUDY DIRECTOR

• Yong Wang, M.M.

  Shandong Cancer Hospital and Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgery

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: June 1, 2008
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

CN (1)