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| ID | Type | Description | Link |
|---|---|---|---|
| STU00002443 | Other Identifier | Northwestern University IRB |
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Lack of funding
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiation therapy uses high-energy x-rays to kill cancer cells. Motexafin gadolinium may make cancer cells more sensitive to radiation therapy and combination chemotherapy. Giving motexafin gadolinium together with chemotherapy, rituximab, and radiation therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving motexafin gadolinium together with combination chemotherapy, rituximab, and whole-brain radiation therapy and to see how well it works in treating patients with newly diagnosed primary central nervous system lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed every 3 months for the first year, every 3-4 months for the second year, every 4-6 months until the fifth year, and then annually thereafter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | Infusion will be given at week 2, week 4, week 6 and week 8. Infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated. |
| |
| Cytarabine | Drug | Administered by IV over 3 hours at a dose of 3 g/m2/day for 2 days given at week 17 and week 21. |
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| Methotrexate | Drug | Administered by IV at dose of 3.5 grams/m2 on day 1 of week 1, week 3, week 5, week 7 and week 9; if CSF was positive it will also be given intrathecally on day 8 of week 1, week 3, week 5, week 7 and week 9. |
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| Motexafin gadolinium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of motexafin gadolinium (MGd) and rituximab added to high-dose methotrexate, procarbazine hydrochloride, and vincristine (MPV) chemotherapy | To evaluate toxicity of motexafin gadolinium (MGd) and rituximab to high-dose methotrexate, procarbazine hydrochloride, and vincristine (MPV) chemotherapy at Day 1 (every 2 weeks), After 5th cycle, After 7th cycle, Pre Radiation Theray, Post Radiation Therapy, and Post ara-c. | Day 1 (every 2 weeks), After 5th cycle, After 7th cycle, Pre Radiation Theray, Post Radiation Therapy, and Post ara-c. |
| Toxicity of MGd added to whole-brain radiotherapy (WBRT) | To evaluate the toxicity of MGd added to whole-brain radiotherapy (WBRT). | Day 1 (every 2 weeks), After 5th cycle, After 7th cycle, Pre Radiation Theray, Post Radiation Therapy, and Post ara-c. |
| Tumor-selective uptake of MGd | To evaluate Tumor-selective uptake of MGd | Day 1 (every 2 weeks), After 5th cycle, After 7th cycle, Pre Radiation Theray, Post Radiation Therapy, and Post ara-c. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (complete remission [CR] and partial remission [CR]) to pre-radiation chemo-immunotherapy (R-MPV with MGd) | MRI scan will be done with each neurologic evaluation. Neuropsychologic evaluation will be repeated approximately 6 months after the completion of therapy and at 6 months intervals thereafter for total of 2 years. | Every 3 months for the first year after completed treatment, every 4 months for the second year, every 6 months until the 5th year and then annually. |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary CNS lymphoma (PCNSL) diagnosed by brain biopsy, CSF cytology, or vitreal biopsy
Newly diagnosed disease
Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial MRI or CT scan (defined as the presence of hypo-, iso- or hyperdense parenchymal contrast-enhancing, usually homogeneously) mass lesion(s) and meet at least one of the following criteria:
Measurable (defined as reproducibly measurable disease in two perpendicular dimensions on radiologic study) or evaluable disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M. Evens, DO, MS | Robert H. Lurie Cancer Center | Principal Investigator |
| Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center | Principal Investigator |
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| Procarbazine hydrochloride | Drug | Taken orally, 100 mg/m2 days 1-7 of the 1st, 3rd, and 5th cycles of induction therapy. |
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| Vincristine sulfate | Drug | Administered by IV at a dose of 1.4mg per meter squared on weeks 1, 3, 5, 7 and 9. |
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| Radiation therapy | Radiation | Given at weeks 11 through 16. |
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| Complete response rate to pre-radiation chemo-immunotherapy (R-MPV with MGd) | Repeat CSF or ocular exam will be done 3 months after completion of treatment in those patients who had evidence of CSF or ocular involvement at diagnosis. CSF will be sampled at each visit. Ocular exams will occur every 3 months for the 1st year then every 4-6 months. Further exams will only be done as needed to rule out recurrent lymphoma. | Every 3 months after completion of treatment, exams every 3 months for the first year then every 4 - 6 months thereafter. |
| Overall survival at 1 year | To assess overall survival rate. | Every 3 months for the first year after completed treatment, every 4 months for the second year, every 6 months until the 5th year and then annually. |
| Event-free survival at 1 year | To assess event-free survival rate. | Every 3 months for the first year after completed treatment, every 4 months for the second year, every 6 months until the 5th year and then annually. |
| Progression-free survival at 1 year | To assess progression-free survival rate. | Every 3 months for the first year after completed treatment, every 4 months for the second year, every 6 months until the 5th year and then annually. |
| Neurotoxicity of R-MVP + MGd based on pre- and post-treatment neuropsychologic testing | MR perfusion and MR spectroscopy at baseline and serially when MRI imaging is done to assess response rates using these alternate forms of imaging. | At baseline |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008223 | Lymphoma |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003561 | Cytarabine |
| D008727 | Methotrexate |
| C437683 | motexafin gadolinium |
| D011344 | Procarbazine |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
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