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15861. Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma

and oral dexamethasone daily on days 1-4 and 15-18. Arm II: The second group receives VAD plus oral PSC 833. Patients receive oral PSC 833 every 6 hours beginning on day 1 and continuing for 20 doses. Patients receive lower dose vincristine IV over 96 hours and lower dose doxorubicin IV over 96 hours on days 2-5 and oral dexamethasone daily on days 2-5 and 16-19. Treatment in both arms repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of 2 courses (...) , patients are reevaluated, and those with stable or responding disease continue treatment for 2 courses beyond maximum response. Doxorubicin is discontinued in patients who receive a maximum lifetime dose but still have stable or responding disease. Patients are followed every 2 months for survival. PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study over approximately 20 months. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial

1999 Clinical Trials

15862. Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

criteria for progression. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide. Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 (...) by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide. Drug: Bicalutamide Other Name: Casodex Drug: Flutamide Other Name: Eulexin Drug: Nilutamide Other Names: Anandron Nilandron Procedure: Conventional Surgery Surgical castration Other Name: Castration Experimental: Arm II Arm II: Chemo/hormonal therapy for 3 x 8-week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine

1999 Clinical Trials

15863. High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer

the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas. Describe the toxicity of these high dose chemotherapy regimens. Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen. Describe the pharmacokinetics of escalating doses of paclitaxel (...) given as a 24-hour continuous infusion. Determine the disposition of carboplatin administered in the IC-T regimen. OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate. Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed

1999 Clinical Trials

15864. Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

if the diseased kidney makes up the bulk of the tumor burden. All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. Patients (...) : More than 3 months Hematopoietic: No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: AST and ALT no greater than 5 times normal Renal: Creatinine less than 4.0 mg/dL Cardiovascular: No symptomatic angina No untreated coronary artery disease No refractory arrhythmia No abnormal left ventricular function Pulmonary: No dyspnea on minimal exertion Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease

1999 Clinical Trials

15865. Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

Cancer Biological: aldesleukin Procedure: conventional surgery Phase 2 Detailed Description: OBJECTIVES: Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2. Assess the toxicity associated with this treatment. OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 (...) months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited. Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 14 participants Primary Purpose: Treatment

1999 Clinical Trials

15866. Interleukin-2 in Treating Patients With Metastatic Melanoma

with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 20 patients will be entered. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 20 participants Primary Purpose: Treatment Official Title: TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2 Study Start Date (...) : No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma Contacts

1999 Clinical Trials

15867. Immunotoxin in Treating Patients With Leukemia or Lymphoma

escalation study. Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 15-21 days for up to 10 courses in the absence of disease progression, neutralizing antibodies, or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 patient experiences dose limiting toxicity. PROJECTED ACCRUAL: A maximum of 40 (...) greater than 50,000/mm3* NOTE: *nonleukemic patients Hepatic: AST and ALT less than 5 times normal Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Pulmonary: FEV1, TLC, and DLCO greater than 50% of predicted if pulmonary or mediastinal involvement with tumor greater than one third of total thoracic diameter Other: HIV negative Not pregnant Fertile patients must use effective contraception Serum must neutralize no more than 75% LMB-2 in tissue culture PRIOR

1999 Clinical Trials

15868. 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

15869. 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

15870. 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

15871. 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

15872. 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

15873. 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

15874. 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

15875. 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

15876. 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

15877. 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

15878. 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

15879. 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

15880. 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

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