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NCT ID: NCT00553189 Completed - Solid Tumors Clinical Trials

Safety Study of ABT-888 Plus Topotecan Hydrochloride to Treat Patients With Solid Tumors and Lymphomas

Start date: August 9, 2007
Phase: Phase 1
Study type: Interventional

Background: - PARP is an enzyme that is involved in the repair of damage to DNA. Levels of the enzyme are higher in tumor cells than in normal cells, and may play a part in resistance to cancer chemotherapy and radiation therapy. ABT-888 is an experimental drug that inhibits PARP and may help to increase the effectiveness of cancer treatments designed to damage DNA in cancer cells. - Topotecan is a drug approved by the Food and Drug Administration for treating certain cancers. - This dose escalation study will test the two drugs at successively higher doses in small groups of patients until the highest safe dose is determined. Objectives: - To test the safety of the combination of ABT-888 and Topotecan (TPT) and determine the highest dose of each drug that can be safely given to humans. This is the maximum tolerated dose (MTD). - To learn how the combination of ABT-888 and TPT works in humans and how the body handles the drugs. - To determine the side effects of the combination of ABT-888 and TPT at the tested doses. Eligibility: -Patients with solid tumors, lymphomas and chronic lymphocytic leukemia whose disease has progressed following standard therapy or for whom standard treatments are not available. Design: - ABT-888 and TPT are given in 21-day treatment cycles. At the start of the study, TPT is infused through a vein over 30 minutes about a week before cycle 1 starts. Starting on day 1 of cycle 1, ABT-888 is given by mouth twice a day for 7 days. TPT is given through a vein daily for 4 days starting on day 2. After the last dose of ABT-888 day 7, no more treatment is given for the rest of the 21-day cycle. - For the remaining cycles, ABT-888 is given twice a day by mouth on days 1 to 7 of each cycle, and TPT is given through a vein daily on days 1 to 5 of each cycle. - The first three to six patients enrolled in the study take the smallest study dose of the drugs. If they do not develop significant adverse side effects, successive small groups of patients take the drug at increasingly higher doses until the MTD is reached. Additional patients enrolled receive the MTD. - Patients have periodic clinic visits for their TPT infusions and for tests and examinations. Evaluations include measurement of vital signs, physical examinations, blood and urine tests, electrocardiograms and CT or other imaging tests, such as ultrasound or MRI. Tumor biopsies may be requested to study the effects of the drugs on the...

NCT ID: NCT00513318 Terminated - Multiple Myeloma Clinical Trials

Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies

Start date: August 2004
Phase: N/A
Study type: Observational

This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients with high-risk hematopoeitic malignancies. A novel reduced-intensity preparative regimen for umbilical cord blood transplantation will be used. One to a maximum of three cord blood units, depending on cell count, will be administered to facilitate engraftment. Ten patients will be enrolled with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual within 2-3 years.

NCT ID: NCT00396864 Completed - Cancer Clinical Trials

Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma

Start date: May 2006
Phase: Phase 1
Study type: Interventional

Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies or refractory lymphoma whose disease had progressed after treatment with standard, approved therapies that included 2 stages. The initial stage involved dose escalation to an MTD and determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort at the recommended Phase 2 dose.

NCT ID: NCT00389077 Completed - Tumors Clinical Trials

Trial of Two Schedules of Perifosine for Patients With Solid Tumors or Lymphomas

Start date: January 2005
Phase: Phase 2
Study type: Interventional

This is a study of the drug perifosine for patients who have no standard treatment options. This study is designed to identify which cancer types respond to perifosine, and determine which regimen of perifosine is most effective in each one. Patients with either solid tumors or with lymphomas for whom this protocol represents reasonable or optimal treatment will be randomized to receive either perifosine 100 mg daily or 900 mg weekly until disease progression. Based on currently available data it is anticipated that these doses should be easily tolerated by most patients.

NCT ID: NCT00222443 Completed - Tumors Clinical Trials

Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy

Start date: September 2004
Phase: Phase 1
Study type: Interventional

Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas.

NCT ID: NCT00167180 Terminated - Multiple Myeloma Clinical Trials

Post Transplant Donor Lymphocyte Infusion

Start date: January 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with blood cancers.

NCT ID: NCT00152126 Completed - Neuroblastoma Clinical Trials

Chemotherapy With CD133+ Select Autologous Hematopoietic Stem Cells for Children With Solid Tumors and Lymphomas

Start date: August 2003
Phase: N/A
Study type: Interventional

Studies have provided evidence that residual microscopic malignant cells in autologous bone marrow or blood stem cell grafts can contribute to posttransplant relapse. Researchers are currently exploring different methods in an attempt to purify or "purge" the stem cell product to minimize the risk of tumor contamination. The CD133+ antigen is a protein contained on or "expressed" on numerous cells in the human body including specific hematopoietic progenitor (blood forming) cells. However, this antigen is not expressed on certain cancer cells including neuroblastoma. A technique using the investigational CliniMACS cell sorting device has been developed in an effort to filter out only those stem cells that express this CD133+ antigen in order to infuse a hematopoietic stem cell product with no tumor contamination potential. The primary objective of this study is to establish safety of treating patients with a high dose chemotherapy regimen of Busulfan and Melphalan followed by autologous CD133+ hematopoietic stem cell support. Transplants recipients are expected to achieve engraftment as defined by an absolute neutrophil count of greater than or equal to 500/mm3 for three consecutive days by day 42-post infusion. Thus, safety of the treatment plan will be evaluated in terms of failure to engraft by this specific time period.

NCT ID: NCT00023166 Terminated - Neoplasm Metastasis Clinical Trials

Phase I Study of PEG-Paclitaxel In Patients With Advanced Solid Tumors & Lymphomas

Start date: May 2001
Phase: Phase 1
Study type: Interventional

Studies of PEG-paclitaxel have been terminated

NCT ID: NCT00006518 Recruiting - HIV Clinical Trials

Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer

Start date: December 6, 2000
Phase:
Study type: Observational

BACKGROUND: - A number of important scientific advances can be made through the study of blood, bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with Kaposi s sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or cancer. - This protocol provides a mechanism to affect a variety of such studies. OBJECTIVES: -Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer. ELIGIBILITY: -Eligibility criteria include age 18 years or older and at least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; malignancy, Castleman s disease, or skin lesions with appearance of Kaposi s sarcoma; or cervical or anal intraepithelial lesion. DESIGN: - Up to 999 subjects will be enrolled in this study. - Blood samples may be collected at the initial visit, and at follow-up visits. - Other fluids/excretions may be collected (such as urine, saliva, semen, and stool). - Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the participants. - Specific risks will be described in a separate consent to be obtained at the time of the biopsy. - Samples will be studied in the HIV and AIDS Malignancy Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.