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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00753415 |
A study to test the safety, tolerability and ability to make an immune response of V934/V935 by using a new prime-boost regimen in cancer patients with selected solid tumors.
Condition | Intervention | Phase |
---|---|---|
Carcinoma Non-Small Cell Lung Breast Cancer Melanoma Upper GI Tract Carcinoma Colon Carcinoma Renal Cell Carcinoma Bladder Carcinoma Prostate Cancer |
Biological: Comparator: V935 Biological: Comparator: V934 EP (3 doses) and V935 (2 doses) Biological: Comparator: V934 EP (5 doses) + V935 (2 doses) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors |
Estimated Enrollment: | 42 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
V935
|
Biological: Comparator: V935
Treatment Group 1: Low-dose and high-dose V935 will be evaluated. The low-dose cohort will be enrolled first, then the high-dose cohort will be enrolled. V935 will be administered in 0.5 mL doses IM every 2 weeks for 2 doses followed by a 4-week observation period (4WOP). |
2: Experimental
V934 EP + V935
|
Biological: Comparator: V934 EP (3 doses) and V935 (2 doses)
Treatment Group 2: The low-dose cohort will be enrolled first then the high-dose cohort will be enrolled. ¶ Low dose cohort V934 will be administered in 0.5 mL doses IM followed by electroporation (EP) every 2 weeks for 3 doses. Following by a 4-week observation period (4WOP), low dose V935 will be administered in 0.5 mL doses IM every 2 weeks for 2 doses, followed by 4WOP. ¶ High dose cohort V934 will be administered in 0.5 mL doses IM followed by EP every 2 weeks for 3 doses. Following a 4WOP, high dose V935 will be administered in 0.5 mL doses IM every 2 weeks for 2 doses, followed by 4WOP. |
3: Experimental
V934 EP + V935
|
Biological: Comparator: V934 EP (5 doses) + V935 (2 doses)
Treatment Group 3: High-dose V934 followed with high-dose V935 will be evaluated. V934 will be administered in 0.5 mL doses IM followed by EP every 2 weeks for 5 doses. Following a 4-week observation period (4WOP), V935 will be administered in 0.5 mL doses IM every 2 weeks for 2 doses, followed by a 4WOP. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Absolute Neutrophil count (ANC), >=1,500 /µL Platelets, >=100,000 /µL Hemoglobin, >= 9 g/dL Serum creatinine or calculated creatinine clearance, <=1.5 X institutional upper limit of normal (ULN) OR >=60 mL/min for patients with creatinine levels > 1.5 X institutional ULN (Creatinine clearance should be calculated per institutional standard.) Serum total bilirubin, <= 1.5 X ULN OR Direct bilirubin <= ULN for patients with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT), <= 2.5 X ULN Alkaline Phosphatase, <= 2.5 X ULN OR Liver fraction should be <= 2.5 X ULN for patients with unfractionated serum alkaline phosphatase> 2.5 X ULN
Prothrombin time (PT)/Partial thromboplastin time (PTT) OR INR, <=1.2 X ULN Prothrombin time (PT)/Partial thromboplastin time (PTT) <=1.2 X ULN OR INR, <=1.2 X ULN <=1.2 X ULN
Exclusion Criteria:
A patient meeting any of the following criteria is not eligible to participate in this study:
Contact: Toll Free Number | 1-888-577-8839 |
United States, Colorado | |
Call for Information | Recruiting |
Denver, Colorado, United States, 80211-5222 | |
United States, Florida | |
Call for Information | Recruiting |
Tampa, Florida, United States, 33612 | |
United States, Pennsylvania | |
Call for Information | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Call for Information | Recruiting |
Houston, Texas, United States, 77024 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_541, V934-002 |
Study First Received: | September 15, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00753415 |
Health Authority: | United States: Food and Drug Administration |
Genital Neoplasms, Male Prostatic Diseases Urogenital Neoplasms Kidney cancer Urologic Neoplasms Melanoma Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Kidney Diseases Breast Diseases Bladder neoplasm Cystocele |
Skin Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Breast Neoplasms Renal cancer Genital Diseases, Male Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Carcinoma, Renal Cell Nevus Adenocarcinoma Prostatic Neoplasms Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |