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15821. Suramin in Treating Patients With Recurrent Primary Brain Tumors

No renal disease resulting in hospitalization Cardiovascular: No ongoing anticoagulation for deep vein thrombosis (DVT) No residual symptoms from DVT after discontinuation of anticoagulation No cardiac disease resulting in hospitalization Pulmonary: No pulmonary disease resulting in hospitalization Other: No peripheral neuropathy of any etiology HIV negative No pregnant or nursing women Adequate contraception required during and for 12 months following protocol therapy PRIOR CONCURRENT THERAPY (...) : Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for glioblastoma multiforme No more than 1 prior chemotherapy regimen for anaplastic astrocytoma, malignant oligodendroglioma, or malignant mixed glioma At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Completion of 1 course of conventional external radiotherapy required At least 4 weeks since radiotherapy Surgery: Decompressive surgery for clinically suspected

1999 Clinical Trials

15822. Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer

, stage IV adenocarcinoma of the breast Previously untreated or prior adjuvant chemotherapy only CR or PR following 3-5 courses of induction chemotherapy for current diagnosis with one of the following: Cyclophosphamide/doxorubicin Cyclophosphamide/methotrexate/fluorouracil Cyclophosphamide/mitoxantrone No active CNS metastases on CT or MRI Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women Menopausal status: Pre- or postmenopausal Performance status: ECOG 0-2 (...) % of predicted Other: No preexisting peripheral neuropathy No HIV antibody No history of second malignancy within 5 years except: Nonmelanomatous skin cancer Cervical carcinoma in situ No pregnant or nursing women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Hematologically recovered from prior chemotherapy Endocrine therapy: Failure on 1 prior hormonal regimen required for ER-positive disease (greater than 10 femtomoles) unless visceral metastatic crisis requires immediate

1999 Clinical Trials

15823. Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

ejection fraction at least 50% by MUGA No abnormal cardiac conduction documented as second- or third-degree heart block or bundle branch block Pulmonary: DLCO at least 60% of predicted Other: Not HIV positive No history of second malignancy within 5 years except: Nonmelanomatous skin cancer In situ carcinoma of the cervix No pregnant women PRIOR CONCURRENT THERAPY: At least 3 courses of induction therapy required, with regimen at the discretion of the investigator No disease progression during

1999 Clinical Trials

15824. Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma

on regimen A concurrently with maintenance. Maintenance (day 1 is day 43 of Induction): Courses of intermediate dose methotrexate/leucovorin calcium and high dose cytarabine (ID MTX/CF/HD ARA-C) and modified APO alternate every 3 weeks. Patients receive a total of 15 courses (8 of ID MTX/CF/HD ARA-C and 7 of Modified APO). ID MTX/CF/HD ARA-C: Patients receive methotrexate IV over 24 hours on day 1, leucovorin calcium IV or orally every 6 hours on days 2 and 3, cytarabine IV over 48 hours on days 2 to 4 (...) , and methotrexate IT on day 1 of courses 1, 3, and 5. Filgrastim (G-CSF) is administered beginning on day 5 and continuing until blood counts recover. Modified APO: Patients receive vincristine IV on day 1, oral mercaptopurine on days 1-5, doxorubicin IV over 15 minutes on day 1, and oral prednisone three times a day on days 1-5. Arm II: Induction: Patients receive treatment as in arm I except that patients with CNS disease also receive methotrexate IT on days 15, 29, and 36. Maintenance (day 1 is day 43

1999 Clinical Trials

15825. Monoclonal Antibody Therapy and Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia in Remission

or die. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody therapy in treating patients with acute promyelocytic leukemia in remission. Condition or disease Intervention/treatment Phase Leukemia Biological: lintuzumab Drug: cytarabine Drug: idarubicin Phase 2 Detailed Description: OBJECTIVES: I. Evaluate the antileukemic effects of humanized anti-CD33 monoclonal antibody M195 (...) (HuM195) against minimal residual disease in patients with acute promyelocytic leukemia (APL) by using a reverse transcription-polymerase chain reaction for the mutated retinoic acid receptor-alpha to detect changes in minimal residual disease. II. Assess the disease free and overall survival of patients with APL receiving HuM195 for minimal residual disease. III. Evaluate the safety and toxicity of HuM195 in these patients. IV. Evaluate whether HuM195 elicits a human anti-human antibody response

1999 Clinical Trials

15826. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma

-2 12.5% of stem cell reinfused. Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused Biological: filgrastim 5 ug/kg daily following stem cell reinfusion Drug: cisplatin Course 2 - 100 mg/m2 at an infusion rate of 25 mg/hr Drug: doxorubicin hydrochloride Course 1 - 150 mg/m2 by continuous intravenous infusion for 96 hours. Drug: ifosfamide (...) Course 1 - 14 gm/M2 by continuous intravenous infusion for 96 hours. Drug: melphalan Course 2 - 75 mg/m2 infused at a rate of 5 mg/minute Procedure: peripheral blood stem cell transplantation Administered on Day 0 following high-dose chemotherapy in both courses 1 and 2 Outcome Measures Go to Primary Outcome Measures : Number of Participants With Grade 3 Bilirubin [ Time Frame: 2 years after completion of treatment ] Criteria for early termination of this feasibility study: > 2 patients experience

1999 Clinical Trials

15827. Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors

. Patients with normal alpha fetoprotein (AFP) and human chorionic gonadotropin (hCG) tumor marker levels after completion of treatment on arm I or II undergo surgical resection of all residual masses. Patients who have no residual malignant tumor or undergo complete resection of only a mature teratoma receive no further therapy. Patients on arm I who undergo complete resection of residual malignant tumor receive 2 additional courses of VP-16 and CDDP without bleomycin. Patients on arm II who undergo (...) ) with or without high-dose carboplatin, etoposide, and cyclophosphamide plus autologous bone marrow or peripheral blood stem cell transplantation in male patients with poor- or intermediate-risk germ cell tumors. Compare the toxicity of these regimens in these patients. Compare prospectively the prognosis in terms of the rate of decline of the serum tumor markers, human chorionic gonadotropin (hCG) and alpha-fetoprotein (AFP), in patients treated with these regimens. Correlate hCG and AFP with complete

1999 Clinical Trials

15828. Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma

: OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 72-hour continuous infusion in patients with relapsed multiple myeloma. II. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. III. Determine the duration of response and survival following bryostatin 1 in these patients. OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or 2 courses beyond complete remission. Response is assessed (...) after every 4 courses. Patients are followed for survival. PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be entered into this study over 1.25 years. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title: PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA Study Start Date : January 1997 Actual Primary Completion Date : January 1999 Actual Study Completion Date

1999 Clinical Trials

15829. Bryostatin 1 in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

in cohorts of patients who fail to respond to bryostatin alone. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. IV. Determine the duration of response and survival following treatment with bryostatin 1. OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or until 2 courses beyond documentation of complete remission. Response is assessed after every 4 courses. Patients with disease progression (...) who continue to meet the eligibility criteria receive vincristine within 2 hours after completion of each bryostatin 1 infusion. Groups of 3-6 patients receive escalated doses of vincristine until the maximum tolerated dose with bryostatin 1 is determined. Courses repeat every 2 weeks, as above; no individual dose escalation is allowed. No concurrent steroids are permitted. Patients are followed for survival. PROJECTED ACCRUAL: A total of 25 evaluable patients with low-grade NHL or CLL

1999 Clinical Trials

15830. Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer

daily flutamide. On day 4, patients undergo orchiectomy or begin monthly LHRH analogue therapy with leuprolide or goserelin. Patients randomized to receive suramin begin a 12-week course 8-25 days after orchiectomy/LHRH therapy. Hydrocortisone replacement therapy begins concomitantly with suramin and continues for at least 3 months after the completion of suramin treatment or until disease progression intervenes. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 800-1,000 patients (...) at least 60 mL/min BUN no greater than twice normal Cardiovascular: No myocardial infarction within 6 months No NYHA class III/IV status No history of thromboembolic or hemorrhagic cerebrovascular accident No disseminated intravascular coagulation No anticoagulant therapy (aspirin allowed for other uses) Other: No active bacterial infection No HIV or hepatitis B infection No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ cancer of any

1999 Clinical Trials

15831. Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

infusion for a total of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4 courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy. PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 140 (...) times a week for 52 weeks Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5 Other Names: interferon alfa-2b IFN-A Experimental: Adjuvant Biochemotherapy Cisplatin IV Days 1-4; Vinblastine IVPB Days 1-4; Dacarbazine (DTIC) IVPB on Day 1; IFN-A is given subcutaneously on days 1-5; IL-2 continuous infusion for 96 hours on Days 1-4. Each course repeated every 21 days for 4 courses. Biological: Aldesleukin (IL-2) Infusion for a total of 96 hours on days 1-4 Other Names: IL-2

1999 Clinical Trials

15832. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

. Patients in complete or partial remission receive 2 courses past best response (minimum 6 courses). Patients with stable disease after 3 courses may be removed from study. Patients are followed every 6 months for 2 years, then annually for survival. PROJECTED ACCRUAL: Approximately 97 patients will be accrued for this study over 2 years. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 53 participants Intervention Model: Single Group (...) or leptomeningeal CNS disease Lumbar puncture not required prior to study PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Other: HIV negative (testing required for patients at risk) No uncontrolled infection No other serious medical condition that would interfere with evaluation of study

1999 Clinical Trials

15833. Cladribine in Patients With Mantle Cell Lymphoma

, Southern blotting, or in situ hybridization), and compare these results with immunohistochemical demonstration of bcl-1 protein expression. VI. Determine the proliferative rate of MCL by immunohistochemistry and DNA content flow cytometry. V. Summarize the toxic effects associated with this treatment. OUTLINE: Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in complete remission (...) for a maximum of 6 courses; response is assessed after every 2 courses. Patients in complete remission or with stable disease discontinue treatment and are followed; those with disease progression at any time are removed from study. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years. Drug: cladribine Outcome Measures Go to Primary Outcome Measures : Overall response [ Time Frame: Up to 4 years ] Overall survival [ Time Frame: Up

1999 Clinical Trials

15834. 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

15835. 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

15836. 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

15837. 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

15838. 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

15839. 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

15840. 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

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