Phase 2
N=33
Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma
CNS Lymphoma · CNS Brain Cancer · Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00596154 ↗Enrolled (actual)
33
Serious AEs
42.4%
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants Evaluated for Toxicity — 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Evaluated for Toxicity |
33 | — |
| SECONDARY Overall Response Rates |
1; 22; 6; 1; 3 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00596154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.