Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma

Phase 2

Completed

• Conditions: CNS Lymphoma; CNS Brain Cancer; Non-Hodgkin's Lymphoma
• Interventions: Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide

• Registration Number: NCT00596154
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to determine the safety of this new treatment offered in this study. PCNSL can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. Most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. Some patients younger than age 60 also develop these side effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Status Verified: 2023-02
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Results First Submitted: 2023-09-28
• Results First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.

A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.

• Patients must be HIV-1 negative.
• Patient must have left ventricular ejection fraction ≥ 50%.
• Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration.
• Patients must have adequate bone marrow function (defined as peripheral leucocyte count >3000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg%), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min/1.73M2).
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
• Patients must be between 18 and 72 years-old.
• Patients must sign an informed consent.

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Exclusion Criteria

• Prior cranial irradiation
• Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
• Pre-existing immunodeficiency such as renal transplant recipient.
• Prior treatment with chemotherapy for CNS lymphoma.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide	Rituximab, methotrexate (MTX), procarbazine and vincristine (R-MPV). The peripheral blood stem cell (PBSC) harvest procedure will be performed at the discretion of the hematology attending (usually after the 1st or 2nd cycle of R-MPV)and high dose chemotherapy Busulfan, Thiotepa, and Cyclophosphamide. Patients will be off study at the time of death. All patients will be followed for survival every 6 months throughout their lifetime. Survival status may be obtained by phone call, clinical visit or medical records (e.g. physician notes/laboratory results of clinic or hospital visit.

Primary Outcome Measures

Name	Time	Method
Number of Participants Evaluated for Toxicity	1 year	To evaluate the safety and efficacy of the use of R-MPV followed by high-dose chemotherapy using thiotepa, cyclophosphamide and busulfan with stem cell rescue in patients with newly diagnosed PCSNL.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rates	after 10 weeks (5 cycles)	To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.

Trial Locations

Locations (3)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States