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

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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Key information

Conditions

CNS Lymphoma CNS Brain Cancer Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: 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.

Primary outcomes

Number of Participants Evaluated for Toxicity

Time frame: 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 outcomes

Overall Response Rates

Time frame: after 10 weeks (5 cycles)

To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Acronym: PCNSL

Important dates

Study start: 2004
Primary completion: 2023
Study completion: 2023
First posted: Jan 16, 2008
Registry last updated: Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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