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15661. Response to treatment with the leukocyte-derived immunomodulator IMREG-1 in immunocompromised patients with AIDS-related complex. A multicenter, double-blind, placebo-controlled trial. (Abstract)

Response to treatment with the leukocyte-derived immunomodulator IMREG-1 in immunocompromised patients with AIDS-related complex. A multicenter, double-blind, placebo-controlled trial. To determine if a 6-month course of therapy with IMREG-1, a leukocyte-derived immunomodulator, slows disease progression in patients with AIDS-related complex.Randomized, double-blind trial.Five academic- and three community-based clinics.Immunocompromised patients (143) with HIV.IMREG-1 or placebo every 2 weeks (...) (13 doses).Twelve of forty-eight patients on placebo and 5 of 95 patients on IMREG-1 experienced adverse events (AIDS-defining opportunistic infection or neoplasm, wasting syndrome, HIV-associated encephalopathy, or peripheral sensory neuropathy). Based on an intention-to-treat analysis, Kaplan-Meier event probabilities were 26% for the placebo group and 6% for the IMREG-1 group (P less than 0.001); based on the Cox proportional hazards model, the relative risk for patients on placebo compared

1991 Annals of internal medicine Controlled trial quality: predicted high

15662. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

or active infection) Not HIV positive AND receiving antiretroviral therapy (HAART) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for head and neck cancer No concurrent colony stimulating factors during first course of therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease At least 3 months since prior chemotherapy as initial treatment Endocrine therapy: No prior hormonal therapy for head and neck cancer Radiotherapy: See Disease Characteristics At least 3

2000 Clinical Trials

15663. Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

by ganciclovir IV 2 times daily on days 28-41. Treatment repeats for up to 3 courses in patients with stable or responsive disease. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 14-20 patients will be accrued for this study within 18-24 months. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title: A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase (...) than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac dysfunction by history and exam No ischemic heart disease that may be considered anesthetic or operative risk Pulmonary: No lung disease that may be considered anesthetic or operative risk Other: HIV negative Not pregnant or nursing No acute viral, bacterial, or fungal infection requiring medication within 14 days prior to study No patient with greater than 2 L of ascites at the time of intraperitoneal infusion

2000 Clinical Trials

15664. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma

by a rest period of 3-4 weeks. Patients with complete or partial response may receive 6 additional courses in the absence of disease progression or unacceptable toxicity. Patients with minor response (25-50% tumor regression) may also receive further courses of treatment. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 22-41 patients will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose (...) that is not controlled by antibiotics No grade 3 or worse preexisting neurological abnormality, regardless of causality HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2 other prior chemotherapy regimens (e.g., one frontline plus one salvage regimen) At least 2 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior radiotherapy and recovered Surgery: Not specified Other: See Disease Characteristics

2000 Clinical Trials

15665. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer

phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer. Condition or disease Intervention/treatment Phase Kidney Cancer Biological: aldesleukin Drug: histamine dihydrochloride Phase 2 Detailed Description: OBJECTIVES: Determine the clinical efficacy and safety of subcutaneous (SC) histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal (...) for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy

2000 Clinical Trials

15666. Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)

courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses. Biological: recombinant fowlpox-prostate specific antigen vaccine Given IM Other Names: fowlpox-PSA vaccine recombinant fowlpox-PSA vaccine rF-PSA Biological: recombinant vaccinia prostate-specific antigen vaccine Given intradermally Other Names: Prostate Specific Antigen Expressing Vaccinia Virus Vaccine rV-PSA vaccine vaccinia prostate-specific antigen vaccine vaccinia-prostate-specific antigen (...) , multicenter, dose-escalation study of recombinant fowlpox prostate-specific antigen (PSA) vaccine. SAFETY COHORT: The first cohort of 3 patients receives vaccination with recombinant fowlpox-PSA vaccine intramuscularly (IM). Treatment repeats every 4 weeks for 3 courses. In the absence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at the dose level immediately higher than the first cohort dose level. In the presence of unacceptable toxicity

2000 Clinical Trials

15667. Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma

diffuse small cleaved cell lymphoma AIDS-related lymphoblastic lymphoma Additional relevant MeSH terms: Layout table for MeSH terms Lymphoma Lymphoma, Non-Hodgkin Acquired Immunodeficiency Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases (...) . OUTLINE: Patients receive gallium nitrate IV continuously on days 1-7. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Patients who relapse after achieving CR may be retreated in the absence of disease progression. Treatment for relapse after a second CR is at the discretion of the principal investigator. Patients with leptomeningeal disease at study entry must receive

1999 Clinical Trials

15668. SWOG-9320 Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

throughout treatment, plus antiretroviral therapy at the discretion of the treating physician. Treatment repeats every 21 days for a maximum of 6 courses. Patients with progressive disease are removed from study after 2 courses. Remaining patients receive an additional 2 treatment courses and are then restaged. Patients without stable or progressive disease receive 2 more courses in the absence of unacceptable toxicity. Patients with positive bone marrow at study entry receive CNS prophylaxis with 5 (...) evenly spaced doses of intrathecal cytarabine during the first 2 treatment courses and on day 1 of each subsequent course. Patients with positive CSF cytology at study entry receive intrathecal cytarabine on days 1-5 of the first treatment course and on day 1 of each subsequent course if CSF negative after 5 daily doses. Patients whose CSF remains positive after 5 days receive 5 evenly spaced doses of intrathecal methotrexate during the second treatment course. Patients with negative bone marrow

1999 Clinical Trials

15669. Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors

, vinblastine, and bleomycin (CISCA VB). Patients are assigned to regimen B if they previously received etoposide (VP-16) as part of a first-line treatment, such as bleomycin, VP-16, and cisplatin (BEP). Regimen A: Patients receive cisplatin IV over 2 hours, VP-16 IV over 2 hours, and ifosfamide IV over 1 hour on days 1-5 (PEI). Regimen B: Patients receive cisplatin and etoposide as in regimen A and vinblastine IV on days 1 and 2 (VeIP). Treatment on both regimens continues every 3 weeks for 2 courses (...) . Patients with refractory disease at day 43 are taken off study. Part II: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive 2 additional courses of PEI or VeIP. Arm II: Patients receive 1 additional course of PEI or VeIP, followed by 1 course of high-dose carboplatin IV over 2 hours, VP-16 IV over 2 hours, and cyclophosphamide IV over 1 hour on days 1-4. Autologous bone marrow and/or PBSC are reinfused on day 7 of the fourth course for patients on both arms. Patients on both arms

1999 Clinical Trials

15670. Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease

adenopathy is defined as a palpable nodal mass greater than 10 cm. in diameter or a mediastinal mass with a maximum mass diameter measuring greater than or equal to 1/3 the maximum chest wall diameter (see Appendix III). Patients with intra-abdominal disease. (Patients with pelvic disease: ileofemoral, inguinal or parailiac nodes are eligible for this study.) Patients with B symptoms. Patients known to have a positive antibody test for the human immunodeficiency virus (HIV) or who have a clinical (...) diagnosis of acquired immunodeficiency syndrome. HIV testing is not a requirement for study entry. Patients who have undergone a staging laparotomy. Female patients who are pregnant. Note: men and women of childbearing age must be advised in the use of adequate contraception. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please

1999 Clinical Trials

15671. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors

for Human Immunodeficiency Virus. Laboratory criteria for protocol entry: WBC ≥ 3000/ul Platelets 3 100,000/ul Cr Clearance > 50 cc/min* * (unless renal dysfunction is due to tumor obstructing the ureters in which case eligibility will be determined by the Principal Investigator). Age ≥ 15 years. Signed informed consent. Exclusion Criteria: Presence of active infection Concurrent treatment with chemotherapy or Inability to comply with the treatment protocol or to undergo the specified follow-up tests (...) of carboplatin. Part A: Patients receive paclitaxel IV continuously on day 1 and ifosfamide IV over 4 hours on days 2-4. Autologous peripheral blood stem cells (PBSC) are harvested on days 11-13. Filgrastim (G-CSF) is administered subcutaneously (SC) twice daily beginning 6 hours after completion of paclitaxel and ifosfamide infusions and continuing until the last day of leukapheresis. Treatment continues every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Before

1999 Clinical Trials

15672. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma

in at least 2 peripheral blood smears Stage II/III disease documented sometime during clinical course Stage III defined by presence of at least 1 of the following: Hemoglobin less than 8.5 g/dl Serum calcium greater than 12 mg/dl Advanced lytic bone lesions High M-component production rates: IgG greater than 7 g/dl IgA greater than 5 g/dl Urinary light chain greater than 4 g/24 hours Stage II disease defined by absence of Stage III characteristics but presence of at least 1 of the following: Hb less than (...) , or medical inability to tolerate the procedure No increased anesthetic risk No HIV infection Priority of multiple donors (in order given): ABO compatible Age over 18 Same sex as recipient A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 70

1999 Clinical Trials

15673. Chemotherapy and Bone Marrow Transplantation in Treating Patients Acute Myeloid With Leukemia or Myelodysplastic Syndrome

syngeneic or allogeneic marrow transplantation following cytoreduction that includes total-body irradiation. III. Determine the early and late toxic effects produced by these chemotherapy regimens in this patient population. OUTLINE: Low-risk patients (those in first complete remission (CR) who achieved CR with 1 course of chemotherapy) are treated on Regimen A. High-risk patients (those in second or subsequent CR who required more than 1 course of chemotherapy to achieve first CR or those (...) No increased anesthetic risk due to pre-existing illness HIV negative PATIENT CHARACTERISTICS: Age: 6 months to 60 years Performance status: No preterminal or moribund patients Life expectancy: No severe limits on life expectancy due to diseases other than leukemia Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal No severe hepatic disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min

1999 Clinical Trials

15674. Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

: No Criteria DISEASE CHARACTERISTICS: Histologically proven stage I-IV Hodgkin's lymphoma Must have refractory or relapsed disease, defined by 1 of the following: Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy Disease in second or greater remission Patients should be encouraged to undergo transplantation prior to a third salvage regimen Patients previously treated with multiple regimens considered on a case-by-case basis No chemoresistant disease (...) /min BUN less than 20 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO, FEV_1, and FVC greater than 50% of predicted OR Resting pO_2 greater than 70 mm Hg on room air Other: HIV negative No severe neurologic or emotional disorders No active infection No other disease that would limit life expectancy Not pregnant Fertile patients must use effective contraception Adequate psychosocial support required PRIOR CONCURRENT THERAPY: Biologic therapy Not specified

1999 Clinical Trials

15675. Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

of the following conditions: Response to initial chemotherapy without obtaining complete response (CR)(refractory lymphoma) Relapse after chemotherapy-induced CR if tumor volume reduced by at least 25% for more than 1 month after completion of 1-3 courses of salvage chemotherapy (chemosensitive relapse) No chemoresistant disease, defined by the following conditions: Unresponsive or progressive disease during initial chemotherapy Relapse after chemotherapy-induced CR if tumor volume not reduced by at least 25 (...) % after completion of 1-3 courses salvage chemotherapy (chemoresistant relapse) No CNS involvement by lymphoma Syngeneic bone marrow transplantation offered to patients with consenting identical twin donor NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT

1999 Clinical Trials

15676. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors

histologic subtype allowed Seminoma only allowed if ineligible for radiotherapy Failed to achieve complete remission (CR) following at least 3 courses of a standard platinum-containing regimen or experienced clear relapse following CR obtained with such a regimen Absence of tumor markers in the presence of stable residual masses after initial treatment may be allowed (surgical biopsy should be performed; if medically safe, to confirm persistence of disease and rule out mature teratoma or fibrosis) Prior (...) : LVEF at least 50% No other serious cardiac disease that would preclude transplantation Pulmonary: DLCO, FEV1, and FVC at least 50% predicted pO2 at least 70 mm Hg on room air Other: HIV negative No other concurrent serious psychiatric, neurologic, neoplastic, immunologic, or other medical problem that would preclude transplantation Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See

1999 Clinical Trials

15677. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma

who achieve CR after completion of course 6 receive 2 additional courses. Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 29 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: PHASE II STUDY OF HIGH-DOSE CYCLOPHOSPHAMIDE PLUS RECOMBINANT HUMAN (...) treatment (yes vs no). Patients receive cyclophosphamide IV over 90 minutes on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until blood counts recover. Treatment continues every 2 weeks for 4 courses in the absence of disease progression or stable disease. Patients who achieve complete remission (CR) after completion of course 4 receive 2 additional courses. Patients who achieve partial remission (PR) after completion of course 4 receive 2 additional courses, and those

1999 Clinical Trials

15678. SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease

. without 3 courses of doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility. III. Identify subgroups of patients (based on age, gender, tumor histology, number of disease sites, and presence of high neck presentation) that are particularly responsive to these treatments. OUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage equipment (4-10 MeV (...) pulmonary condition Other: No serious medical condition other than Hodgkin's disease No known AIDS or HIV-associated complex No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix No pregnant or lactating women Adequate contraception required of fertile patients Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration; imaging studies for tumor measurement completed within 28

1999 Clinical Trials

15679. Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

-LET photon therapy Phase 2 Detailed Description: OBJECTIVES: I. Determine the response rate and disease free survival of HIV seronegative patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when treated with high intensity, brief duration combination chemotherapy: alternating courses of ifosfamide/cytarabine/etoposide and cyclophosphamide/doxorubicin, each with methotrexate/vincristine/dexamethasone. II. Determine the toxicity of these regimens in HIV negative (...) patients. OUTLINE: Patients are stratified by participating institution and disease type (diffuse small noncleaved cell lymphoma vs L3 ALL). Patients receive cyclophosphamide IV over 5-10 minutes on days 1 through 5 and oral prednisone on days 1 through 7, followed by alternating courses of: 2) ifosfamide IV over 1 hour on days 8 through 12, methotrexate IV over 24 hours on day 8; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24

1999 Clinical Trials

15680. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

cytoreduction undergo harvest of bone marrow before IFRT. Patients receive cytoreduction comprising high-dose cytarabine IV over 1 hour every 12 hours, cisplatin IV over 10 hours, and dexamethasone three times daily on days 1 and 2. At 3 weeks, a second course is administered if tumor reduction is at least 25% and in the absence of unacceptable toxicity. Patients with involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active disease sites, at least 90% of which can (...) and spirometry) greater than 60% predicted Other: HIV negative No serious organ dysfunction (unless caused by lymphoma) No active bacterial, viral, or fungal infection No active peptic ulcer disease No uncontrolled diabetes mellitus No other malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No other serious medical or psychiatric illness that would preclude study Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy

1999 Clinical Trials

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