CNS Brain Cancer, CNS Lymphoma, Non-Hodgkin's Lymphoma
Conditions
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.
Interventions
OTHERRituximab, 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rates | after 10 weeks (5 cycles) | To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Newly Diagnosed Primary CBS Lymphoma/PCNSL 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. Participants will be off study at the time of death. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not Evaluable | 2 |
Baseline characteristics
| Characteristic | Newly Diagnosed Primary CBS Lymphoma/PCNSL |
|---|---|
| Age, Continuous | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 33 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 33 |
| other Total, other adverse events | 33 / 33 |
| serious Total, serious adverse events | 14 / 33 |
Outcome results
Primary
Number of Participants Evaluated for Toxicity
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | Number of Participants Evaluated for Toxicity | 33 Participants |
Secondary
Overall Response Rates
To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.
Time frame: after 10 weeks (5 cycles)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | Overall Response Rates | Complete Response | 22 Participants |
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | Overall Response Rates | Progression Free | 1 Participants |
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | Overall Response Rates | Partial Response | 6 Participants |
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | Overall Response Rates | Stable Disease | 1 Participants |
| Newly Diagnosed Primary CBS Lymphoma/PCNSL | Overall Response Rates | Not Evaluable | 3 Participants |