RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to the drug. Giving genetically modified peripheral blood stem cells during or after treatment may prevent side effects caused by chemotherapy. PURPOSE: This clinical trial studies O6-benzylguanine and temozolomide in combination with genetically modified peripheral blood stem cells in treating patients with newly diagnosed glioblastoma multiforme.

NCT01269424

Conditions

1. Glioblastoma Multiforme

Interventions

1. Biological: MGMTP140K-encoding retroviral vector
2. Drug: O6-benzylguanine
3. Drug: temozolomide
4. Other: laboratory biomarker analysis
5. Procedure: autologous hematopoietic stem cell transplantation
6. Procedure: in vitro-treated peripheral blood stem cell transplantation
7. Radiation: radiation therapy

MeSH:Glioblastoma

HPO:Glioblastoma multiforme

Feasibility and safety of infusing autologous P140K MGMT-transduced hematopoietic progenitors into patients with GBM. --- P140K ---

Quantitate P140K transduced hematopoietic cells from the bone marrow and peripheral blood in patients infused with P140K transduced CD34 progenitors. --- P140K ---

Quantitate P140K transduced hematopoietic cells from the bone marrow and peripheral blood in patients infused with P140K transduced CD34 progenitors. --- P140K --- --- P140K ---

To evaluate the in vivo enrichment of P140K expressing hematopoietic cells by repeated treatments of BG and TMZ. --- P140K ---

- Prior diagnosis of malignant disease within a three year period with the exception of surgically cured basal cell carcinoma or carcinoma in situ of the cervix - Mental incapacity or psychiatric illness preventing informed consent Glioblastoma Multiforme Glioblastoma OBJECTIVES: Primary - To evaluate the feasibility of introducing and expressing P140K MGMT cDNA from a lentiviral-based provirus in autologous hematopoietic stem cells harvested from Glioblastoma multiforme (GBM) patients. --- P140K ---

- To assess the safety associated with infusion of autologous hematopoietic stem cells transduced ex vivo with a lentiviral vector expressing P140K MGMT in patients with GBM. --- P140K ---

Secondary - To determine whether any patients who receive P140K MGMT-transduced CD34 cells tolerate O6-benzylguanine (BG) and dose-escalated temozolomide (TMZ) without myelosuppression. --- P140K ---

- To evaluate the ability to detect P140K-transduced BG and TMZ-resistant hematopoietic cells from the bone marrow and peripheral blood in patients infused with P140K-transduced CD34 progenitors. --- P140K ---

- To evaluate the ability to detect P140K-transduced BG and TMZ-resistant hematopoietic cells from the bone marrow and peripheral blood in patients infused with P140K-transduced CD34 progenitors. --- P140K --- --- P140K ---

- To evaluate the feasibility of in vivo enrichment of P140K-expressing hematopoietic cells by repeated treatments of BG and TMZ at doses that appear therapeutic for GBM. - To evaluate the efficacy of various types of chemotherapy with or without radiotherapy on conditioning the patient's bone marrow to host the transduced autologous hematopoetic stem cells. --- P140K ---

- Cohort 1 (LV P140K MGMT gene transfer after concurrent chemoradiotherapy): Patients receive radiotherapy (60cGy in 30 2cGy daily doses) and TMZ 75mg/m2 /daily for 6 weeks, cell infusion at week 7 (T0) followed by BG 120 mg/m2 intravenous infusion over 1h and TMZ 50 mg/m2/day x 5 days, every 28 days (starting on T+28) for 6 cycles. --- P140K ---

- Cohort 2 (LV P140K MGMT gene transfer prior to concurrent chemoradiotherapy): Patients receive BG 120mg/m2 intravenous infusion over 1h and TMZ 400 mg/m2 one dose given on day T-2 or T-3 days prior to cell infusion, followed within 72-96 hours by radiotherapy (60cGy in 30 2cGy daily doses) and concurrent BG + TMZ at 50 mg/m2/day x 5 days, every 28 days,starting on T+28 for a total of 7 cycles of BG + TMZ. - Cohort 3 (intra-patient dose escalation of TMZ in patients with evidence of P140K-marked cells): Dose escalation of TMZ in patients with evidence of P140K marked cells in vivo given as described above for cohort 1 or cohort 2. After completion of radiotherapy, patients will receive BG + TMZ at 50 mg/m2/day x 5 days. --- P140K ---

- Cohort 2 (LV P140K MGMT gene transfer prior to concurrent chemoradiotherapy): Patients receive BG 120mg/m2 intravenous infusion over 1h and TMZ 400 mg/m2 one dose given on day T-2 or T-3 days prior to cell infusion, followed within 72-96 hours by radiotherapy (60cGy in 30 2cGy daily doses) and concurrent BG + TMZ at 50 mg/m2/day x 5 days, every 28 days,starting on T+28 for a total of 7 cycles of BG + TMZ. - Cohort 3 (intra-patient dose escalation of TMZ in patients with evidence of P140K-marked cells): Dose escalation of TMZ in patients with evidence of P140K marked cells in vivo given as described above for cohort 1 or cohort 2. After completion of radiotherapy, patients will receive BG + TMZ at 50 mg/m2/day x 5 days. --- P140K --- --- P140K ---

- Cohort 2 (LV P140K MGMT gene transfer prior to concurrent chemoradiotherapy): Patients receive BG 120mg/m2 intravenous infusion over 1h and TMZ 400 mg/m2 one dose given on day T-2 or T-3 days prior to cell infusion, followed within 72-96 hours by radiotherapy (60cGy in 30 2cGy daily doses) and concurrent BG + TMZ at 50 mg/m2/day x 5 days, every 28 days,starting on T+28 for a total of 7 cycles of BG + TMZ. - Cohort 3 (intra-patient dose escalation of TMZ in patients with evidence of P140K-marked cells): Dose escalation of TMZ in patients with evidence of P140K marked cells in vivo given as described above for cohort 1 or cohort 2. After completion of radiotherapy, patients will receive BG + TMZ at 50 mg/m2/day x 5 days. --- P140K --- --- P140K --- --- P140K ---

This pilot phase I trial studies the side effects and best dose of human immunodeficiency virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are then re-infused into the patient. These genetically modified stem cells may help the body make cells that are resistant to HIV infection.

NCT02343666

Conditions

1. Human Immunodeficiency Virus 1 Positive
2. Stage I Adult Hodgkin Lymphoma
3. Stage I Adult Non-Hodgkin Lymphoma
4. Stage II Adult Hodgkin Lymphoma
5. Stage II Adult Non-Hodgkin Lymphoma
6. Stage III Adult Hodgkin Lymphoma
7. Stage III Adult Non-Hodgkin Lymphoma
8. Stage IV Adult Hodgkin Lymphoma
9. Stage IV Adult Non-Hodgkin Lymphoma

Interventions

1. Biological: C46/CCR5/P140K Lentiviral Vector-transduced Autologous HSPCs
2. Drug: Carmustine
3. Biological: Filgrastim
4. Other: Laboratory Biomarker Analysis
5. Drug: O6-Benzylguanine
6. Drug: Plerixafor

MeSH:HIV Infections Acquired Immunodeficiency Syndrome Lymphoma Lymphoma, Non-Hodgkin Hodgkin Disease

HPO:Hodgkin lymphoma Lymphoma Non-Hodgkin lymphoma

Inclusion Criteria: - HIV-1 seropositive - Stable, continuous antiretroviral treatment, defined as a multi-drug regimen (excluding zidovudine, also known as azidothymidine [AZT], Retrovir) prior to enrollment, as demonstrated by HIV plasma viral load < 50 copies/mL - Previously untreated non-Hodgkin lymphoma or Hodgkin lymphoma; all stages of disease are allowed; also eligible are patients who have started or completed one or more cycles of treatment as part of a planned first line regimen, or those who have received local radiation or surgery or corticosteroids for disease control - Planned treatment with standard first line therapy for non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) - Karnofsky performance score >= 70% - Subjects must agree to use effective means to prevent conception from enrollment through completion of the study - Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment - Subjects must be on a prophylactic regimen for Pneumocystis jiroveci pneumonia, or agree to begin such treatment, if CD4+ cell counts are observed to be =< 200/ul in peripheral blood - Able to understand, and the willingness to give, informed consent for the study Exclusion Criteria: - Central nervous system (CNS) lymphoma: CNS involvement by lymphoma, including parenchymal brain or spinal cord lymphoma or known presence of leptomeningeal disease prior to registration - Patients with renal, hepatic, pulmonary, or cardiac disease that exclude delivery of standard chemotherapy - Active (uncontrolled) infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV) - Hepatitis B surface antigen positive - Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic acid (RNA), with clinical evidence of cirrhosis as determined by the principal investigator - Requiring active treatment for Toxoplasma gondii infection - Malignancy other than lymphoma, unless (1) in complete remission and more than 5 years from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) superficial basal cell and squamous cell cancers of the skin - History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months - Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian) - Any concurrent or past medical condition that, in the opinion of the investigator, would exclude the subject from participation - Patients who have received a vaccine for HIV-1 or any prior gene modified cell product, at any time - A medical history of noncompliance with HAART or medical therapy - Pregnant women or nursing mothers - Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at the time of study entry is allowed) - Known hypersensitivity to any of the products used in the trial - G-CSF (Neupogen, filgrastim), plerixafor (Mozobil), or any components of the chemotherapeutic agents or O6BG/BCNU in vivo selection regimens Inclusion Criteria: - HIV-1 seropositive - Stable, continuous antiretroviral treatment, defined as a multi-drug regimen (excluding zidovudine, also known as azidothymidine [AZT], Retrovir) prior to enrollment, as demonstrated by HIV plasma viral load < 50 copies/mL - Previously untreated non-Hodgkin lymphoma or Hodgkin lymphoma; all stages of disease are allowed; also eligible are patients who have started or completed one or more cycles of treatment as part of a planned first line regimen, or those who have received local radiation or surgery or corticosteroids for disease control - Planned treatment with standard first line therapy for non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) - Karnofsky performance score >= 70% - Subjects must agree to use effective means to prevent conception from enrollment through completion of the study - Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment - Subjects must be on a prophylactic regimen for Pneumocystis jiroveci pneumonia, or agree to begin such treatment, if CD4+ cell counts are observed to be =< 200/ul in peripheral blood - Able to understand, and the willingness to give, informed consent for the study Exclusion Criteria: - Central nervous system (CNS) lymphoma: CNS involvement by lymphoma, including parenchymal brain or spinal cord lymphoma or known presence of leptomeningeal disease prior to registration - Patients with renal, hepatic, pulmonary, or cardiac disease that exclude delivery of standard chemotherapy - Active (uncontrolled) infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV) - Hepatitis B surface antigen positive - Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic acid (RNA), with clinical evidence of cirrhosis as determined by the principal investigator - Requiring active treatment for Toxoplasma gondii infection - Malignancy other than lymphoma, unless (1) in complete remission and more than 5 years from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) superficial basal cell and squamous cell cancers of the skin - History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months - Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian) - Any concurrent or past medical condition that, in the opinion of the investigator, would exclude the subject from participation - Patients who have received a vaccine for HIV-1 or any prior gene modified cell product, at any time - A medical history of noncompliance with HAART or medical therapy - Pregnant women or nursing mothers - Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at the time of study entry is allowed) - Known hypersensitivity to any of the products used in the trial - G-CSF (Neupogen, filgrastim), plerixafor (Mozobil), or any components of the chemotherapeutic agents or O6BG/BCNU in vivo selection regimens Human Immunodeficiency Virus 1 Positive Stage I Adult Hodgkin Lymphoma Stage I Adult Non-Hodgkin Lymphoma Stage II Adult Hodgkin Lymphoma Stage II Adult Non-Hodgkin Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Non-Hodgkin Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Non-Hodgkin Lymphoma HIV Infections Acquired Immunodeficiency Syndrome Lymphoma Lymphoma, Non-Hodgkin Hodgkin Disease PRIMARY OBJECTIVES: I. To determine the safety and feasibility of infusing C46/CCR5/P140K lentiviral vector-transduced autologous hematopoietic stem progenitor cells (HSPC) (gene modified, HIV-protected HSPC) after standard first line treatment of lymphoma in patients with HIV infection. --- P140K ---

Determine the correlation between the level of MGMT(P140K) marking with toxicity and response to O6BG/BCNU chemotherapy. --- P140K ---

STEM CELL INFUSION: Patients receive CD34+ gene-modified C46/CCR5/P140K lentiviral vector-transduced autologous HSPC intravenously (IV) within 2 to 8 days, but no later than 28 days, after completion of the last cycle of first line treatment for lymphoma. --- P140K ---

This clinical trial studies genetically modified peripheral blood stem cell transplant in treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy

NCT01769911

Conditions

1. Adult Nasal Type Extranodal NK/T-cell Lymphoma
2. AIDS-related Diffuse Large Cell Lymphoma
3. AIDS-related Diffuse Mixed Cell Lymphoma
4. AIDS-related Diffuse Small Cleaved Cell Lymphoma
5. AIDS-related Immunoblastic Large Cell Lymphoma
6. AIDS-related Lymphoblastic Lymphoma
7. AIDS-related Peripheral/Systemic Lymphoma
8. AIDS-related Small Noncleaved Cell Lymphoma
9. Anaplastic Large Cell Lymphoma
10. Angioimmunoblastic T-cell Lymphoma
11. Cutaneous B-cell Non-Hodgkin Lymphoma
12. Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
13. Hepatosplenic T-cell Lymphoma
14. HIV-associat
15. HIV-associated Hodgkin Lymphoma
16. Intraocular Lymphoma
17. Nodal Marginal Zone B-cell Lymphoma
18. Noncutaneous Extranodal Lymphoma
19. Peripheral T-cell Lymphoma
20. Recurrent Adult Burkitt Lymphoma
21. Recurrent Adult Diffuse Large Cell Lymphoma
22. Recurrent Adult Diffuse Mixed Cell Lymphoma
23. Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
24. Recurrent Adult Grade III Lymphomatoid Granulomatosis
25. Recurrent Adult Hodgkin Lymphoma
26. Recurrent Adult Immunoblastic Large Cell Lymphoma
27. Recurrent Adult Lymphoblastic Lymphoma
28. Recurrent Adult T-cell Leukemia/Lymphoma
29. Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
30. Recurrent Grade 1 Follicular Lymphoma
31. Recurrent Grade 2 Follicular Lymphoma
32. Recurrent Grade 3 Follicular Lymphoma
33. Recurrent Mantle Cell Lymphoma
34. Recurrent Marginal Zone Lymphoma
35. Recurrent Mycosis Fungoides/Sezary Syndrome
36. Recurrent Small Lymphocytic Lymphoma
37. Refractory Hairy Cell Leukemia
38. Small Intestine Lymphoma
39. Splenic Marginal Zone Lymphoma
40. Stage I AIDS-related Lymphoma
41. Stage II AIDS-related Lymphoma
42. Stage III AIDS-related Lymphoma
43. Stage IV AIDS-related Lymphoma
44. T-cell Large Granular Lymphocyte Leukemia
45. Testicular Lymphoma
46. Waldenström Macroglobulinemia

Interventions

1. Drug: carmustine
2. Drug: cytarabine
3. Drug: melphalan
4. Drug: etoposide
5. Drug: O6-benzylguanine
6. Procedure: autologous hematopoietic stem cell transplantation
7. Procedure: peripheral blood stem cell transplantation
8. Other: laboratory biomarker analysis

MeSH:Mycoses Burkitt Lymphoma Lymphoma Leukemia Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Hodgkin Disease Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Waldenstrom Macroglobulinemia Lymphoma, Large-Cell, Anaplastic Lymphoma, T-Cell, Peripheral Leukemia, Hairy Cell Lymphomatoid Granulomatosis Lymphoma, Extranodal NK-T-Cell Intraocular Lymphoma Leukemia, Large Granular Lymphocytic Lymphoma, AIDS-Related Immunoblastic Lymphadenopathy

HPO:Anaplastic large-cell lymphoma B-cell lymphoma Burkitt lymphoma Chronic lymphatic leukemia Cutaneous T-cell lymphoma Hodgkin lymphoma Leukemia Lymphoma Monoclonal immunoglobulin M proteinemia Non-Hodgkin lymphoma T-cell lymphoma

Determine the correlation of the level of O6-methylguanine- methyltransferase (MGMT) (P140K) marking with toxicity and response. --- P140K ---

This phase I/II trial studies the side effects and best dose of temozolomide when given together with radiation therapy, carmustine, O6-benzylguanine, and patients' own stem cell (autologous) transplant in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Giving chemotherapy, such as temozolomide, carmustine, and O6-benzylguanine, and radiation therapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or plerixafor, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

NCT00669669

Conditions

1. Glioblastoma
2. Gliosarcoma

Interventions

1. Radiation: 3-Dimensional Conformal Radiation Therapy
2. Procedure: Autologous Hematopoietic Stem Cell Transplantation
3. Drug: Carmustine
4. Biological: Filgrastim
5. Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
6. Radiation: Intensity-Modulated Radiation Therapy
7. Other: Laboratory Biomarker Analysis
8. Drug: O6-Benzylguanine
9. Drug: Plerixafor
10. Radiation: Proton Beam Radiation Therapy
11. Drug: Temozolomide

MeSH:Glioblastoma Glioma Gliosarcoma

HPO:Glioblastoma multiforme Glioma

Inclusion Criteria: - Patients with glioblastoma multiforme or gliosarcoma - The patient or legal guardian must be able to comprehend the informed consent form and sign prior to patient enrollment - Karnofsky performance status at time of study entry must be >= 70% - Life expectancy of >= 3 months - Patients must agree to undergo repeat clinical neurological examinations and brain magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of chemotherapy - White blood cell (WBC) > 3000/ul - Absolute neutrophil count (ANC) > 1500/ul - Platelets > 100,000/ul - Hemoglobin > 10 gm/100ml - Total and direct bilirubin < 1.5 times upper limit of laboratory normal - Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 3 times upper limit of laboratory normal - Alkaline phosphatase =< 3 times upper limit of laboratory normal - Blood urea nitrogen (BUN) < 1.5 times upper limit of laboratory normal - Serum creatinine < 1.5 times upper limit of laboratory normal - Left ventricular ejection fraction (LVEF) >= 40%, however, subjects with a LVEF in the range of 40-49% should have cardiology clearance prior to intervention - MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must demonstrate an unmethylated or hypomethylated MGMT promoter status Exclusion Criteria: - Patients with cardiac insufficiency and a LVEF of < 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment - Patients with active pulmonary infection and/or pulse oximetry < 90% and a corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 70% of predicted - Active systemic infection - Patients who are human immunodeficiency virus (HIV) positive - Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception - Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC) or prior nitrosourea - Diabetes mellitus - Bleeding disorder - Methylated or hypermethylated MGMT promoter status within tumor tissue - Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol - Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers Inclusion Criteria: - Patients with glioblastoma multiforme or gliosarcoma - The patient or legal guardian must be able to comprehend the informed consent form and sign prior to patient enrollment - Karnofsky performance status at time of study entry must be >= 70% - Life expectancy of >= 3 months - Patients must agree to undergo repeat clinical neurological examinations and brain magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of chemotherapy - White blood cell (WBC) > 3000/ul - Absolute neutrophil count (ANC) > 1500/ul - Platelets > 100,000/ul - Hemoglobin > 10 gm/100ml - Total and direct bilirubin < 1.5 times upper limit of laboratory normal - Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 3 times upper limit of laboratory normal - Alkaline phosphatase =< 3 times upper limit of laboratory normal - Blood urea nitrogen (BUN) < 1.5 times upper limit of laboratory normal - Serum creatinine < 1.5 times upper limit of laboratory normal - Left ventricular ejection fraction (LVEF) >= 40%, however, subjects with a LVEF in the range of 40-49% should have cardiology clearance prior to intervention - MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must demonstrate an unmethylated or hypomethylated MGMT promoter status Exclusion Criteria: - Patients with cardiac insufficiency and a LVEF of < 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment - Patients with active pulmonary infection and/or pulse oximetry < 90% and a corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 70% of predicted - Active systemic infection - Patients who are human immunodeficiency virus (HIV) positive - Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception - Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC) or prior nitrosourea - Diabetes mellitus - Bleeding disorder - Methylated or hypermethylated MGMT promoter status within tumor tissue - Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol - Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers Glioblastoma Gliosarcoma Glioblastoma Glioma Gliosarcoma PRIMARY OBJECTIVES: I. Determine the safety and feasibility of infusing autologous granulocyte colony-stimulating factor (G-CSF) (filgrastim) mobilized stem cells transduced with a Phoenix-gibbon ape leukemia virus (GALV)-pseudotype vector expressing methylguanine methyltransferase (MGMT) (P140K). --- P140K ---

V. Determine the correlation of the level of MGMT (P140K) marking with toxicity, temozolomide dose achieved, and response. --- P140K ---