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HIV Course

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15841. Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

support vs conventional cyclophosphamide, methotrexate, and fluorouracil (CMF), both following doxorubicin induction, in women with high risk breast cancer. OUTLINE: This is a randomized, multicenter study. Patients are stratified by the number of positive axillary nodes (4-9 vs at least 10) and by center. Patients are randomized to one of two treatment arms. Arm I: Patients receive induction therapy consisting of doxorubicin IV every 3 weeks for 4 courses followed by consolidation therapy consisting (...) of cyclophosphamide IV, methotrexate IV, and fluorouracil IV every 3 weeks for 8 courses. At week 4 of consolidation therapy, patients receive radiotherapy to the breast, chest wall, and axilla over 3-5 weeks or as appropriate. Following recovery from consolidation therapy, patients receive maintenance therapy consisting of oral tamoxifen daily for 5 years. Arm II: Patients receive induction therapy as in arm I followed by consolidation therapy consisting of stem cell mobilization with high dose cyclophosphamide

1999 Clinical Trials

15842. Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma

. OUTLINE: Patients are stratified by disease histology (International Working Formulation (IWF) A-C vs IWF D-F) and center. Patients receive aminocamptothecin IV continuously on days 1-3. Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease, partial response (PR), or complete response (CR) may receive 2 additional courses past best response (minimum of 6 courses if PR or CR). Patients are followed (...) Performance status: CALGB 0-2 Unless hypersplenism or biopsy-proven bone marrow involvement: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin normal AST no greater than 4 times normal Creatinine normal No suspected HIV infection No second malignancy within past 5 years except: Curatively treated carcinoma of the cervix Curatively treated basal cell skin cancer No uncontrolled infection or other serious medical condition No psychiatric condition that precludes

1999 Clinical Trials

15843. Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon Alfa in Treating Patients With Recurrent Ovarian Cancer

of IFN-A, paclitaxel, and 177Lu-CC49. VI. Monitor any antitumor effects of this treatment in these patients. OUTLINE: This is a dose escalation study of paclitaxel, topotecan, lutetium LU 177 monoclonal antibody CC-49 (177Lu-CC49), and yttrium Y 90 monoclonal antibody CC49 (90Y-CC49). Patients receive interferon alfa subcutaneously on days 1, 3, 5, and 7; paclitaxel intraperitoneally (IP) on day 4 or topotecan IP on day 6; and 177Lu-CC49 IP on day 6. Treatment continues every 6 weeks for 2 courses (...) ; and 177Lu-CC49 IP on day 6. Treatment continues every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel and decreasing doses of 177Lu-CC49 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity. Once the MTD of paclitaxel is determined, the dose of 177Lu-CC49 is escalated. Once the MTD of 177Lu-CC49

1999 Clinical Trials

15844. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia

who achieve CR and who have adequate organ function and performance status are then randomly assigned to Arm IIA or IIB for Consolidation. At selected centers, patients in CR after their first Consolidation course who are under age 71 and in very good clinical condition are treated on Regimen A (in lieu of a second Consolidation course). The following acronyms are used: AMSA Amsacrine, NSC-249992 ARA-C Cytarabine, NSC-63878 BAVC BCNU/AMSA/VP-16/ARA-C BCNU Carmustine, NSC-409962 DHAD Mitoxantrone (...) impairment from disease other than AML Hematopoietic: Not applicable Hepatic: Bilirubin less than 2 x ULN Renal: Creatinine less than 2 x ULN Cardiovascular: LVEF at least 50% No severe cardiac disease Pulmonary: No severe pulmonary disease Other: HIV seronegative (if tested) No uncontrolled infection No severe neurologic, metabolic, or psychiatric disease No other concomitant disease that precludes protocol therapy No other progressive malignant disease PRIOR CONCURRENT THERAPY: No prior chemotherapy

1999 Clinical Trials

15845. T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia

general anesthesia for marrow donation and a 5-day course of filgrastim (G-CSF) with 2 daily leukaphereses PATIENT CHARACTERISTICS: Age: Under 50 (50 and over allowed on a case-by-case basis) Performance status: Age 16 and over: Karnofsky 70-100% Under age 16: Lansky 50-100% Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL (in the absence of liver involvement) AST less than twice normal (in the absence of liver involvement) Renal: Creatinine normal OR Creatinine clearance greater (...) than 60 mL/min Cardiovascular: Asymptomatic or LVEF greater than 50% at rest, with improvement during exercise Pulmonary: Asymptomatic or DLCO greater than 50% predicted (corrected for hemoglobin) Other: No known hypersensitivity to mouse protein or chicken egg products No active viral, bacterial, or fungal infection HIV-1, HIV-2, HTLV-1, and HTLV-2 negative No other concurrent medical condition that would preclude transplantation Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy

1999 Clinical Trials

15846. Combination Chemotherapy in Treating Patients With Lymphoma

Lymphoma Actual Study Start Date : October 30, 1995 Actual Primary Completion Date : February 4, 2004 Actual Study Completion Date : February 4, 2004 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Arm I 3 courses of early intensification: First course: Ifosfamide (IFF) IV continuously and Etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) administered (...) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest. Second course: IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in first course. Third course: Carmustine IV over 1 hour on day -6, ARA-C

1999 Clinical Trials

15847. Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer

conventional salvage therapy In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7 Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase No blast crisis Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events (...) to other serious illness Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL AST/ALT no greater than twice normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% No severe hypertension Pulmonary: DLCO, FEV_1, and FVC at least 50% Other: HIV negative No active infection at time of transplant No advanced diabetes No significant neurologic deficit No active drug or substance abuse

1999 Clinical Trials

15848. Interleukin-2 in Treating Patients With Mycosis Fungoides

of patients treated with this regimen. Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients. OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses. Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 (...) disease, including psoriasis No uncontrolled peptic ulcer disease No uncontrolled infection No history of adverse reaction to interleukin-2 HIV and HTLV-I negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior systemic or topical chemotherapy (6 weeks since prior mitomycin or nitrosoureas) Endocrine therapy: At least 1 week

1999 Clinical Trials

15849. Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma

on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses. Patients are followed every 2 months for 6 months, then every 3 months thereafter (...) : stage IV melanoma recurrent melanoma Additional relevant MeSH terms: Layout table for MeSH terms Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferons Interferon alpha-2 Aldesleukin Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents

2000 Clinical Trials

15850. Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies

Epstein Barr virus (EBV)-specific cytotoxic T lymphocytes IV on days 1, 8, and 15. After the third dose, patients will be observed for 3 weeks. After the 3 week observation period, additional courses of treatment may be given in the absence of disease progression or unacceptable toxicity. Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes (...) transplant. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV. Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic

1999 Clinical Trials

15851. Biological Therapy in Treating Patients With Metastatic Melanoma

maintenance or suppressive therapy HIV negative No history of seizures No retinitis or choroiditis Not pregnant or nursing Negative pregnancy test Fertile patients must use adequate contraception Peripheral blood samples available weekly for 4 consecutive weeks PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since other prior immunotherapy Chemotherapy 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease At least 4 weeks since prior standard or investigational chemotherapy (...) + cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for approximately 1 year after the last infusion. PROJECTED ACCRUAL

1999 Clinical Trials

15852. Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation

(sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients. II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response. III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization. IV. To clone, expand and characterize (...) SC Other Names: GM-CSF Leukine Prokine Biological: aldesleukin Given SC Other Names: IL-2 Proleukin recombinant human interleukin-2 recombinant interleukin-2 Other: laboratory biomarker analysis Correlative studies Outcome Measures Go to Primary Outcome Measures : Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria [ Time Frame: Up to 2 years ] Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort

1999 Clinical Trials

15853. Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma

and after treatment in this patient population. III. Determine somatostatin receptor subtypes in lymphoma biopsy samples from selected patients. OUTLINE: Patients receive fludarabine IV over 10-30 minutes on days 1-5. Patients not currently receiving octreotide, receive a test dose of octreotide subcutaneously on day 1 during course 1 only and then receive octreotide intramuscularly monthly on day 1. Treatment repeats every 28 days for 4-6 courses. Patients then receive octreotide alone for 6-8 courses (...) . Some patients may then receive another 12 courses of octreotide alone, for a total of 2 years of treatment. Patients are followed every 3 months for 5 years or until disease progression. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 34 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW

1999 Clinical Trials

15854. Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

of the following conditions: In partial remission (PR) or CR to and currently enrolled on the MSKCC standard dose salvage regimen with ifosfamide, carboplatin, and etoposide (ICE) In PR or CR after 1-2 other salvage chemotherapy regimens (e.g., 3 courses of dexamethasone, high-dose cytarabine, and cisplatin (DHAP); 2 courses of cyclophosphamide, mechlorethamine, vincristine, procarbazine, and prednisone (C-MOPP)) No prior ifosfamide Low-grade lymphoma In second or greater remission or chemosensitive relapse (...) Pulmonary: DLCO at least 50% predicted (corrected for hemoglobin and alveolar ventilation) Other: HIV negative No uncontrolled infection No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy

1999 Clinical Trials

15855. Clinically significant drug interactions with antituberculosis agents. (Abstract)

Clinically significant drug interactions with antituberculosis agents. Standard short-course regimens for tuberculosis are used worldwide with very few problems. Unfortunately, the emergence of multiple drug-resistant tuberculosis in many parts of the world is leading to a diversification of drug regimens and to the use of drugs that are more toxic per se and more likely to interact with others. In addition, the treatment of HIV/AIDS patients with tuberculosis or disease due to Mycobacterium

1994 Drug safety : an international journal of medical toxicology and drug experience

15856. Insights from monitoring the CPCRA didanosine/zalcitabine trial. Terry Beirn Community Programs for Clinical Research on AIDS. (Abstract)

Insights from monitoring the CPCRA didanosine/zalcitabine trial. Terry Beirn Community Programs for Clinical Research on AIDS. The design, conduct, and analysis of clinical trials that evaluate the safety and efficacy of treatment interventions in patients with HIV infection provide many scientific challenges. A recently completed randomized trial of didanosine (ddI) and zalcitabine (ddC), sponsored by the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), is an especially (...) valuable resource for illustrating these challenging issues and for providing insights into how they might be properly addressed. Establishing equivalence of treatment effects on clinical efficacy end points is illustrated through the use of the confidence interval approach. The striking changes in treatment efficacy results that occurred during the course of the CPCRA trial provide important insights into how a data and safety monitoring board can reduce the risk of inappropriate early study

1995 Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association Controlled trial quality: uncertain

15857. A randomized trial (ISS 901) of switching to didanosine versus continued zidovudine after the diagnosis of AIDS. (Abstract)

-treated patients (6%). In our population of patients with advanced disease, switching from AZT to ddI did not produce apparent benefits, suggesting that application of this strategy earlier in the course of human immunodeficiency virus disease should be considered.

1996 Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association Controlled trial quality: uncertain

15858. Fluconazole therapy for histoplasmosis. The National Institute of Allergy and Infectious Diseases Mycoses Study Group. (Abstract)

Fluconazole therapy for histoplasmosis. The National Institute of Allergy and Infectious Diseases Mycoses Study Group. We assessed the efficacy of oral fluconazole (200-800 mg daily) in the treatment of non-life-threatening acute pulmonary histoplasmosis, chronic pulmonary histoplasmosis, or disseminated histoplasmosis in patients without human immunodeficiency virus infection. Of 27 evaluable patients, two had progressive acute pulmonary histoplasmosis, 11 had chronic pulmonary histoplasmosis (...) , and 14 had disseminated histoplasmosis. Median durations of treatment in each of the three groups were 6 months, 7 months, and 11 months, respectively. Nineteen patients were treated with 400 mg of fluconazole daily (two of these patients received 800 mg daily for a portion of their treatment courses), seven were treated with 200 mg daily, and one was treated with 800 mg daily. Treatment was successful in 17 (63%) of 27 cases. Both of the patients with acute pulmonary infection responded to therapy

1996 Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Controlled trial quality: uncertain

15859. Hydroxyurea and didanosine is a more potent combination than hydroxyurea and zidovudine. (Abstract)

Hydroxyurea and didanosine is a more potent combination than hydroxyurea and zidovudine. The in vitro and in vivo antiviral activity of hydroxyurea in combination with either zidovudine or didanosine was evaluated in primary human peripheral mononuclear cells and in a cohort of 29 asymptomatic patients infected with HIV. In vitro, hydroxyurea alone did not significantly affect HIV replication, whereas the combination of hydroxyurea with didanosine was more effective than the combination (...) three groups. Plasma viraemia was not influenced by hydroxyurea monotherapy, and the hydroxyurea-zidovudine combination did not give any advantage over either zidovudine or didanosine monotherapy (0.3-0.5 log decrease in plasma viraemia). In contrast, a 1.1 log drop in plasma viraemia was observed in patients treated with hydroxyurea plus didanosine, this reduction was sustained throughout the 24-week course of the treatment. Combination therapy with hydroxyurea and didanosine exhibited

1997 Antiviral therapy Controlled trial quality: uncertain

15860. High prevalence and coinfection rate of hepatitis G and C infections in intravenous drug addicts. (Abstract)

with human immunodeficiency virus, six were coinfected with hepatitis G virus and hepatitis C virus, and 10 only with hepatitis C virus.Hepatitis G virus infection is highly prevalent in i.v. drug users, but less frequent than hepatitis C virus infection. The fact that all but two patients were coinfected with hepatitis C virus, 75% with one genotype, supports a common route of transmission for both viruses. The course of hepatitis C virus infection is not altered by hepatitis G virus infection. (...) High prevalence and coinfection rate of hepatitis G and C infections in intravenous drug addicts. The hepatitis G virus is a newly discovered RNA virus which is possibly transmitted parenterally. Hepatitis G virus is associated with acute or chronic hepatitis and may lead to cirrhosis and liver cancer, characteristics shared by the hepatitis C virus. Hepatitis C virus is prevalent in drug users, but the frequency and role of hepatitis G virus is not yet well established.One hundred

1997 Journal of hepatology Controlled trial quality: uncertain

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