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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2023-02-02

Brief Summary

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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.

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Detailed Description

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Conditions

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CNS Lymphoma CNS Brain Cancer Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide

Intervention Type OTHER

The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.

On day 2 you will be admitted to the hospital and will receive 3 other drugs:

Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.

Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.

Interventions

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Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide

The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.

On day 2 you will be admitted to the hospital and will receive 3 other drugs:

Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.

Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.

Intervention Type OTHER

Other Intervention Names

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During each cycle, you will receive Rituximab typically as an outpatient on day 1 and then be admitted on day 2 to receive the other chemotherapy. You will be in the hospital for about 5 days and will be re-admitted to the hospital about 9 days later to start the next cycle. After each cycle of chemotherapy you will take a medicine called G-CSF to protect you against infection. PBPCs will be collected when determined by your doctor and may occur with cycle 1 or cycle 2. You will be admitted again for the high-dose chemotherapy and will receive supportive medications to help avoid complications, including antibiotics and blood transfusions. Three drugs, Busulfan, Thiotepa, and Cyclophosphamide will be given to you over 8 days. After a rest period of approximately 1-2 days, we will give your PBPCs (or bone marrow) back to you by vein. You will be in the hospital for at least 3 weeks.

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No