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NCT ID: NCT01216124 Available - Clinical trials for Triple Negative Local Advanced Breast Cancer

Efficacy and Safety Study of Neoadjuvant Chemotherapy for Local Advanced Triple Negative Breast Cancer Patients

Start date: n/a
Phase: N/A
Study type: Expanded Access

The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is based on three standard immunohistochemical biomarkers. In clinical routine, Docetaxel was widely indicated as first-line therapy for breast cancer patients in adjuvant or neoadjuvant settings. Oxaliplatin, trans-1-diaminocyclohexane-platinum, may offer advantages over other platinum agents. Oxaliplatin promotes formation of DNA adducts, preventing DNA replication and transcription and ultimately causing apoptosis. Oxaliplatin was more potent than cisplatin and the Oxaliplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. TNBC patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies. There was no report about Oxaliplatin in the chemotherapy setting for breast cancer patients. The investigators hypothesized that using Oxaliplatin adding to docetaxel would be feasible and active in patients with TNLABC because in vitro findings suggest synergism between the agents. This study was designed to investigate the efficacy and toxicity of oxaliplatin-based regimen as a neoadjuvant chemotherapy setting in triple negative local advanced breast cancer patients

NCT ID: NCT01236287 Available - Immunosuppression Clinical Trials

Special Access for the Use of Voclosporin for Kidney Transplantation

Start date: n/a
Phase:
Study type: Expanded Access

Voclosporin is an investigational medication previously studied to prevent acute rejection in patients who receive a kidney transplant. This study is a compassionate release program where subjects previously participating in the study entitled A Phase 2B, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in denovo Renal Transplant Patients (ISA05-01)" may be eligible to continue to receive voclosporin despite the Phase 2B study being terminated by the sponsor. Under the compassionate release program, subjects previously taking voclosporin may continue to receive the study medication until the drug is FDA-approved and commercially available in the United States. Voclosporin was approved by the FDA in January 2021 for the treatment of active lupus nephritis. The sponsor (now called Aurinia Pharma, U.S.) is willing to continue to provide voclosporin (commercial supply) for the one subject remaining in this special access protocol.

NCT ID: NCT01250808 Available - Multiple Myeloma Clinical Trials

Technology Platform and System Construction of Clinical Evaluation Studies on New Drugs of Hematological Malignancy

Start date: n/a
Phase: N/A
Study type: Expanded Access

Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The previous study pointed out that the dosage and course of Bortezomib including the dose of concomitant drugs used to treatment MM patients did not get the preferred treatment program, so we are going to determine the optimal doses and course of Bortezomib through the prospective, multicenter clinical trial and evaluate the efficiency and safety of different program.

NCT ID: NCT01267461 Available - Colon Cancer Clinical Trials

Evaluation of the Proliferative Activities of Insulin Analogues in Primary Human Tumor Cells

Start date: n/a
Phase: N/A
Study type: Expanded Access

Recently the general medical literature has become aware that the use of certain long-acting insulin analogues could potentially increase cancer risk.During the last few years the investigators group generated information of both scientific and clinical relevance on the proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to evaluate the hypothesis that the proliferative and signalling activities elicited by insulin analogues may have a impact on tumor behavior. In this study the investigators will asses the biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.

NCT ID: NCT01277796 Available - Clinical trials for Cutaneous Leishmaniasis

Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

HECT
Start date: n/a
Phase: N/A
Study type: Expanded Access

Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.

NCT ID: NCT01301664 Available - Clinical trials for Mesenchymal Stem Cells

Cartilage Tissue Engineering

Start date: n/a
Phase: N/A
Study type: Expanded Access

In this study, the investigators explored the hypothesis that osteoarthritic cartilage fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were harvested from one osteoarthritic patient during the total knee arthroplasty surgery. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice. Moreover, the investigators will collect the discard cartilage to develop an acellular cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the investigators will harvest the redundant bone marrow from drilling or useless synovium during the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal stem cells will be transfected with hTERT for rejuvenation and then will be labeled with fluorescent dye PKH26 for application of animal study. To sum up, the investigators plan to use human, natural, and discard materials from the joint replacement surgery to develop appropriate allograft for cartilage repair and hope that one day this ideal would be apply in clinical.

NCT ID: NCT01317953 Available - Clinical trials for Small Cell Lung Carcinoma

Oral Green Tea Extract for Small Cell Lung Cancer

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.

NCT ID: NCT01370330 Available - Neuroblastoma Clinical Trials

131I-Labeled MIBG for Refractory Neuroblastoma: A Compassionate Use Protocol

Start date: n/a
Phase:
Study type: Expanded Access

This is a compassionate use protocol to allow patients with advanced neuroblastoma palliative access to 131I-metaiodobenzylguanidine (131I-MIBG).

NCT ID: NCT01487044 Available - Clinical trials for Diabetic Macular Edema

A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

GUARDIAN
Start date: n/a
Phase: N/A
Study type: Expanded Access

Establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly during the initial treatment period when the VEGF levels are the greatest and then gradually extending the administration frequency to monthly as homeostasis ensues for the treatment of DME, as measured by best-corrected visual acuity.

NCT ID: NCT01590680 Available - Neuroblastoma Clinical Trials

Expanded Access Protocol Using 131I-MIBG

Start date: n/a
Phase:
Study type: Expanded Access

Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG for patients with neuroblastoma or pheochromocytoma / paraganglioma, who otherwise do not qualify for available treatments, or where approved treatment is not commercially available.