University of Vermont

College of Medicine

Vermont Cancer Center

trials_phase1

Phase I Clinical Trials

The Vermont Cancer Center has many Phase I clinical trials.

Status: Active - Recruiting
Study Title:
Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
Purpose: This is a Phase I non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies. The proposed approach would provide a personalized repertoire of antibodies that recognize unique glioblastoma-specific targetable antigens.
ClinicalTrials.gov Identifier: NCT01702792
Primary/Site/Co Investigator: David Krag, MD and Camilo Fadul, MD (Dr. Fadul is at Dartmouth Hitchcock Medical Center in NH)
Contact: Eileen Caffry (802) 656-3447
Information: http://clinicaltrials.gov/ct2/show/record/NCT01702792?term=hybridomas&rank=1
Institution Number: CHRMS M13-145
Protocol Research Type: Investigator Initiated
Status: Active - Recruiting
Study Title:
VCC 0601 – Phase I/II Trial to Evaluate Partial Breast Radiation to the Region of the Lumpectomy Cavity Using Intensity Modulated Radiation Therapy (IMRT) in Elderly Women with Breast Cancer
Purpose: The usual treatment for most women with breast cancer has been the removal of the cancerous lump (breast conserving therapy) followed by daily radiation therapy (a type of X-ray) to the entire breast for 5 to 7 weeks. The purpose of this study is to evaluate whether giving higher daily doses of radiation using intensity modulated radiation (IMRT) in a shorter time (two weeks) can be done safely.
ClinicalTrials.gov Identifier: NCT00337064
Primary/Site/Co Investigator: Ruth Heimann, MD
Contact: Karen Wilson (802) 656-4101
Information: http://www.clinicaltrials.gov/ct2/show/NCT00337064?term=partial+breast+radiation+AND+elderly&rank=1
Institution Number: CHRMS M06-235, VCC 0601
Protocol Research Type: Investigator Initiated
Status: Active - Recruiting
Study Title:
VCC 0901 – Phase I/II Trial to Evaluate Partial Breast Radiation to the Region of the Lumpectomy Cavity Using Intensity Modulated Radiation Therapy (IMRT) in Elderly Women with Breast Cancer
Purpose: The usual treatment for breast cancer removed by lumpectomy consists of 25- 28 radiation treatments to your entire breast followed by 5 - 9 radiation treatments to the excision (lumpectomy) site only.  This study is being done to find out if it is possible to use three dimensional ultrasound (3D US) images to verify the field being treated with radiation is as similar as possible to the planned field.  It is thought that ultrasound images could be collected daily to accurately determine the shape and location of the lumpectomy cavity, which could allow for immediate adjustments in positioning, potentially improving the efficacy of the therapy.
ClinicalTrials.gov Identifier: N/A
Primary/Site/Co Investigator: Ruth Heimann, MD
Contact: Karen Wilson (802) 656-4101
Information: N/A
Institution Number: CHRMS M09-164, VCC 00901
Protocol Research Type: Investigator Initiated
Status: Active - Recruiting
Study Title: CALGB 31102 - Phase I Study of Accelerated Hypofractionated Radiation Therapy with Concomitant Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer
Purpose: For patients with locally-advanced non-small cell lung cancer (NSCLC) and a good performance status, the current “standard of care” is radiation with concurrent chemotherapy.  However, failure of radiotherapy to control gross disease is relatively common, suggesting that there is opportunity to improve radiotherapy techniques to optimize local control and potentially improve patient survival.  Increasing the total dose of radiotherapy with standard fractionation techniques has clearly reached a plateau, but technical advances in radiation therapy and cancer staging have led to an increased ability to target tumors while sparing normal tissue, making it possible to consider increases in the daily radiation dose as a possible avenue of advancement (accelerated hypofractionation).
ClinicalTrials.gov Identifier: NCT01486602
Primary/Site/Co Investigator: Ruth Heimann, MD
Contact: Elizabeth Eldridge (802) 656-2178
Information: N/A
Institution Number: M13-053
Protocol Research Type: Cooperative Group
Status: Active - Recruiting

Study Title: A Phase I/II, Open Label Study of Ad-RTS-hIL-12, an Adenovirus Vector Engineered to Express hIL-12, in Combination with an Oral Activator Ligand, in Subjects with Unresectable Stage III or IV Melanoma. 

Purpose: The purpose of this study is to evaluate the safety and tolerability of intratumoral injections of INXN-2001 at a constant dose in combination with and oral drug INXN-1001 in patients who have unresectable stage III or IV melanoma.  Additional this study will be evaluating anti-tumor activity (as evidenced by reduction in the size of melanoma tumors). 
ClinicalTrials.gov Identifier: NCT01397708
Primary/Site/Co Investigator: Claire Verschraegen, MD
Contact: Kate Murray (802) 656-9401
Information: http://clinicaltrials.gov/ct2/show/NCT01397708?term=ATI001-101&rank=1
Institution Number: M13-027
Protocol Research Type: Industry Sponsored
Status: Active - Recruiting
Study Title: Phase I, First-in-Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects with Advanced Malignancies
Purpose: This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.
ClinicalTrials.gov Identifier: NCT01971515
Primary/Site/Co Investigator: Claire Verschraegen, MD, MS
Contact: Sam Cory (802)-656-9446
Information: http://www.clinicaltrials.gov/ct2/show/NCT01971515?term=01971515&rank=1
Institution Number: CHRMS 14-081
Protocol Research Type: Industry Sponsored
Status: Active - Recruiting
Study Title: A Phase I, Multi-Center, Single-Arm, Open-Label Study of Mocetinostat (MGCD0103) in Combination With Azacitidine in Subjects With Intermediate or High Risk Myelodysplastic Syndrome (MDS)
Purpose: Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.
ClinicalTrials.gov Identifier: NCT02018926
Primary/Site/Co Investigator: Gurpreet Lamba, MD
Contact: Hannah Eldred (802) 656-9441
Information: http://clinicaltrials.gov/ct2/show/NCT02018926?term=mocetinostat&rank=1
Institution Number: CHRMS 14-082
Protocol Research Type: Industry Sponsored
Status: Active - Recruiting
Study Title: EMR100070-001: A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.
Purpose: This is a Phase 1, open-label, dose-escalation trial of MSB0010718C [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications.
ClinicalTrials.gov Identifier: NCT01772004
Primary/Site/Co Investigator: Claire Verschraegen, MD, MS
Contact: Sam Cory (802)-656-9446
Information: http://www.clinicaltrials.gov/ct2/show/NCT01772004?term=NCT01772004&rank=1
Institution Number: CHRMS 14-240
Protocol Research Type: Industry Sponsored

Last modified August 27 2014 02:47 PM