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HIV Course

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15701. Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive an additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study treatment.) Patients are followed every 8 weeks for 2 years. PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued (...) ) that would interfere with oral medication intake No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy

1999 Clinical Trials

15702. Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: This study will accrue 50 patients. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial (...) phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring intravenous antibiotics No frequent vomiting No other medical condition that would interfere with oral medication intake such as partial bowel obstruction No prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell carcinoma of the skin HIV negative No AIDS

1999 Clinical Trials

15703. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas

of irinotecan given in combination with Gliadel wafers in these patients. OUTLINE: This is a dose escalation study. All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity. Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 (...) patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT. Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression. Patients are followed

1999 Clinical Trials

15704. Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer

for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian epithelial carcinoma or primary peritoneal carcinoma at time of initial laparotomy No histologically confirmed noninvasive ovarian malignancy or low malignant potential tumor or carcinomatosis from other nonovarian or peritoneal sites At least three courses of first-line (...) Performance status: GOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times normal No active hepatitis or chronic liver failure Renal: Creatinine no greater than 2 mg/dL Other: Not HIV positive No concurrent immunosuppressive disorders No active systemic infections or active peritonitis Geographically available

1999 Clinical Trials

15705. Interleukin-12 Followed by Interferon Alfa in Treating Patients With Advanced Cancer

of interferon alfa when preceded by a single dose of interleukin-12 in patients with recurrent or metastatic melanoma or other advanced malignancies. OUTLINE: This is a dose-escalation study. Cohorts of 3 patients receive interleukin-12 IV push on day 1, followed by escalating doses of interferon alfa by subcutaneous injection at 24, 48, 72, 96 and 120 hours. Courses repeat every 2 weeks for 6 months (12 courses total) in the absence of unacceptable toxicity and disease progression. Patients achieving (...) partial response or stable disease at the completion of 6 months of therapy may receive additional courses of therapy for up to 24 months. Dose escalation of interferon alfa continues in subsequent cohorts in the absence of dose limiting toxicity (DLT). If 1 of 3 patients experiences DLT at a dose level, then 3 additional patients are entered at that dose level. If 2 of 6 patients experience DLT, then dose escalation stops. The maximum tolerated dose is defined as 1 level below that dose at which 2

1999 Clinical Trials

15706. Flt3L in Treating Patients With Metastatic Colorectal Cancer

of administering flt3 ligand to patients with hepatic metastases from colorectal cancer prior to surgical resection. OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and metastasis resection. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter (...) infection including: Urinary tract infection HIV Viral hepatitis PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other: No immunosuppressives such as: Azathioprine Cyclosporine A Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you

1999 Clinical Trials

15707. Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease

for patients with advanced Hodgkin's disease. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Courses repeat every 4 weeks. Arm II (ChlVPP/PABLOE): Patients receive oral chlorambucil, procarbazine, and prednisolone on days 1-14; vinblastine IV on days 1 and 8; doxorubicin IV on day 29; vincristine IV and bleomycin IV on days 29 and 36; oral etoposide (...) on days 29-31; and oral prednisolone again on days 29-38. Courses repeat every 7 weeks. OR (Hybrid - ChlVPP/EVA): Patients receive vincristine IV on day 1; oral etoposide on days 1-5; oral chlorambucil, procarbazine, and prednisolone on days 1-7; and doxorubicin IV and vinblastine IV on day 8. Courses repeat every 4 weeks. Patients in both arms receive up to 6-8 courses of treatment. Radiotherapy may be given to sites of previous bulk disease for patients in complete remission or uncertain remission

1999 Clinical Trials

15708. Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma

(LI) changes influenced by GM-CSF would predict a group of patients that will respond to this particular course specific design. III. Determine the toxicity of GM-CSF in these patients. OUTLINE: Patients receive subcutaneous injections of sargramostim (GM-CSF) once a day for 5 days. Two to 3 days later, patients receive cyclophosphamide IV over 30-45 minutes on day 1, vincristine IV bolus on day 8, and oral prednisone 4 times a day on days 1-4. Patients also receive subcutaneous injections of GM (...) -CSF starting on day 2 and continuing for 10 days or until neutrophil count is at least 1000/mm3. Treatment continues every 3 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least stable response receive GM-CSF 3 times a week for up to 2 years. Patients are followed every 3-6 months. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued. Study Design Go to Layout table for study information Study Type : Interventional

1999 Clinical Trials

15709. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Central Nervous System Lymphoma

than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: Ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: HIV-1 negative No other active primary malignancy except basal cell skin cancer or carcinoma in situ of the cervix No prior immunodeficiency (e.g., renal transplantation recipient) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for CNS lymphoma Endocrine therapy: Not specified Radiotherapy: No prior cranial (...) of peripheral blood stem cells (PBSC). Patients receive a second course of ARA-C IV beginning 1 month after completion of the first course of ARA-C and continuing daily for 2 days. G-CSF is then administered daily for about 2 weeks. High-dose chemotherapy/transplantation: Patients with stable or responding disease after induction therapy receive high-dose carmustine IV over 1-2 hours on day -7, etoposide IV over 1 hour every 12 hours and ARA-C IV every 12 hours on days -6 to -3, and melphalan IV on day -2

1999 Clinical Trials

15710. Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma

filgrastim (G-CSF) subcutaneously or IV on days 5-12. Patients receive another course of ICE chemotherapy 2-3 weeks after the first course. Biological: filgrastim Experimental: Arm II (2 adverse prognostic factors): Patients receive the first course of ICE as in Arm I Biological: filgrastim Experimental: Arm III Arm III (3 adverse prognostic factors): Patients receive cyclophosphamide IV daily for 2 days, then G-CSF beginning on day 4 until blood stem cells are collected Biological: filgrastim Drug (...) No significant cardiac arrhythmias other than chronic atrial fibrillation Ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: No uncontrolled infection HIV negative At least 5 years since prior malignancy except: Curatively treated cutaneous basal cell carcinoma Carcinoma in situ of the cervix Not pregnant or nursing Fertile women must use effective contraception PRIOR CONCURRENT THERAPY: Must have failed conventional dose standard chemotherapy Contacts and Locations Go to Information from

1999 Clinical Trials

15711. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

in patients with measurable disease treated with this regimen. IV. Further assess the toxicity of this combination in a cohort of prostate cancer patients. V. Examine the survival characteristics of these patients undergoing this regimen. OUTLINE: This an open label study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 2, and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine. Course repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality (...) of life is assessed before each treatment course. Patients are followed until death. PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study over 15-30 months. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 0 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone

1999 Clinical Trials

15712. Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma

the results of the inteleukin-2 receptor assay with treatment outcomes in these patients. OUTLINE: Patients are stratified according to interleukin-2 receptor classification (positive vs negative). Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment repeats every 21 days for 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually (...) ULN Albumin greater than 3.0 g/dL No hepatitis B or C infection Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection requiring anti-infective therapy No other prior invasive malignancy within past 5 years, except: Curatively treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Prior stem cell transplantation allowed At least 4

1999 Clinical Trials

15713. Chemotherapy in Treating Patients With Advanced Solid Tumors

receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study (...) provided by the National Library of Medicine available for: Arms and Interventions Go to Intervention Details: Drug: temozolomide Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2

1999 Clinical Trials

15714. Combination Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

: Patients receive induction chemotherapy with cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, oral prednisone daily on days 2-6, and filgrastim (G-CSF) subcutaneously daily on days 6-10. Treatment is repeated every 14 days for up to 4 courses. Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin IV on day 2, etoposide IV daily on days 1-3, and G-CSF subcutaneously on days 5-12 for course 1, and on day 5 for course 2 and continuing through (...) peripheral blood stem cell (PBSC) collection. Treatment is repeated every 14 days for 2 courses. Following PBSC collection, patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72 hours on days -6, -5, and -4 and cyclophosphamide IV daily on days -3 and -2. PBSCs are infused on day 0. Patients receive G-CSF IV or subcutaneously twice a day beginning on day 1. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. PROJECTED

1999 Clinical Trials

15715. A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer

) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: Stage III patients may begin therapy prior to or following surgery. Patients with undrainable significant third space fluid collection (e.g., pleural effusions, ascites) are entered directly on Consolidation. Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for 4 courses. Patients then receive two 3-week courses of consolidation therapy (...) disorder of cardiovascular system. Cardiac ejection fraction greater than 40%. Pulmonary: No major disorder of pulmonary system. OTHER: Not pregnant or nursing. HIV negative. Hepatitis B or C negative. No patients requiring daily oral corticosteroid therapy. If allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Barre syndrome, ineligible to receive influenza vaccine. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study

1999 Clinical Trials

15716. Effects of Drugs on Cerebral Blood Flow in Patients With Mood Disorders

positron emission tomographic (PET) scans with H(2)(15)O to measure global and local differences in cerebral blood flow during a passive introspection task. Patients receive repeated scans while in different mood states and while participating in placebo controlled therapeutic trials as described by separate protocols. Global and regional cerebral blood flow is correlated with data obtained from participation in other protocols, which include clinical (life charting course of illness parameters, mood (...) ) that would contraindicate participation. No evidence of co-existing major illness after undergoing complete psychiatric (including SADS-LA interview), medical, neurological, and laboratory examinations (including EEG, EKG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis B, syphilis). Negative pregnancy test for women of child bearing potential. Women must not be breast feeding. Negative HIV test, as we are studying primary mood and anxiety disorders and not disorders

1999 Clinical Trials

15717. Evaluation and Follow-up of Patients With Cryptococcosis

and Infectious Diseases (NIAID) Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) Study Details Study Description Go to Brief Summary: This 5-year study will follow the course of disease in previously healthy patients with cryptococcosis who developed the disease for no identifiable reason. Individuals with a positive culture of Cryptococcus neoformans 18 years of age and older without HIV (...) infection or other condition predisposing to cryptococcosis (such as high-dose corticosteroid therapy, sarcoidosis, or a blood cancer) may be eligible for this study. Candidates who test positive for HIV infection may not participate. Participants will have a physical examination, medical history, routine blood tests and assessment of disease activity upon entering the study. Patients who may have active cryptococcosis will also have a lumbar puncture (spinal tap) and additional blood tests. Following

1999 Clinical Trials

15718. Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome). HIV negative. Not pregnant or nursing. Adequate major organ function [in adults: serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 ml/min; and in children serum CR less than or equal to age-adjusted normal (age 12 to 15 maximum serum creatinine 1.2 mg/dl and age (...) ) with G-CSF in agressive B-cell lymphomas. Eligibility: Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL). Patients greater than or equal to 12 years old. Any Stage for PMBL and MGZL. No prior systemic chemotherapy. HIV negative. Design: This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied

1999 Clinical Trials

15719. Interferon Gamma for Drug Resistant Tuberculosis

of causes of secondary immunodeficiency such as HIV or malignancy. Currently receiving cytotoxic therapy, or have received it within the last 3 months. Pregnant or lactating women may not be entered. Patients with a known seizure disorder may not be entered. Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease may not be entered. Patients unable, in the judgment of the PI, to comply with the treatment regimen will be excluded. Contacts and Locations Go (...) sputum samples collected more frequently-weekly for the first 3 months or until three consecutive negative samples are obtained and then monthly throughout the course of therapy. Patients with lung infection will also have repeat CT scans at 6 and 12 months while on interferon gamma. In one or two patients on the drug, blood will be drawn frequently following one injection of gamma interferon (just before the injection and again at 0.25, 0.5, 1, 6, 12, 18, 24 and 48 hours after it) to see

1999 Clinical Trials

15720. A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833

) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses. Stable (...) , or amiodarone. No patients with a history of coronary artery disease with angina pectoris or history of congestive heart failure. No patients with a history of cardiac disease, other than angina pectoris or congestive heart failure, including patients with arrhythmias or conduction system abnormalities will be considered on an individual basis. No patients with symptomatic peripheral neuropathy (grade 2 or greater). No patients with a positive serology for HIV. No patients who are pregnant or unwilling

1999 Clinical Trials

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