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A Study of V934/V935 in Cancer Patients With Selected Solid Tumors (Merck)
This study is currently recruiting participants.
Verified by Merck, January 2009
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00753415
  Purpose

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

Genetics Home Reference related topics: bladder cancer breast cancer
MedlinePlus related topics: Bladder Cancer Breast Cancer Cancer Melanoma Prostate Cancer
U.S. FDA Resources
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

Further study details as provided by Merck:

Primary Outcome Measures:
  • Safety and tolerability of V935 alone and in combination with V934 in patients with solid tumors [ Time Frame: throughout study and at last visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity as a result of vaccination [ Time Frame: throughout study and at last visit ] [ Designated as safety issue: No ]

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Definitive therapies may include various combinations and schedules of surgery, radiotherapy, chemotherapy, and other therapies (e.g., hormonal therapies) delivered alone or as adjuvant/neoadjuvant therapy. In addition, all subjects must show no evidence of progressive disease on routine evaluations prior to enrollment (see exception for prostate carcinoma) Selected Solid Tumors: Stage I to III Non-small cell lung carcinoma (NSCLC); Stage III Breast Cancer; Stage IIB or III Melanoma; Stage II or III Upper GI tract carcinoma (e.g. esophagus, stomach, gallbladder, pancreas); Stage III Colon carcinoma; Stage II, III, or IV (M0 only) Renal cell carcinoma; Stage II, III, or IV (M0 only) Bladder carcinoma; clinically-localized Prostate carcinoma in patients who have completed definitive surgical resection and/or radiation therapy no less than 8 weeks prior to protocol enrollment, but now have a biochemical-only relapse with a rising serum prostate-specific antigen of >0.2 ng/mL after surgery or >1.5 after radiation
  • Patient is >=18 years of age on day of signing informed consent
  • Patient has an ECOG performance status of 0 or 1
  • Patient has adequate organ function as indicated by the following laboratory values:

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

  • Female patient of childbearing potential has a negative serum pregnancy test within 3 days of study enrollment

Exclusion Criteria:

A patient meeting any of the following criteria is not eligible to participate in this study:

  • Patient has been previously treated with any hTERT-containing/targeted vaccine or any prior adenoviral or DNA vaccine
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
  • Patient has known hypersensitivity to any component of study vaccine
  • Patient has any laboratory value (with the exception of absolute lymphocyte count) at the time of study entry and prior to the first vaccine administration that would be considered Grade 3 or Grade 4 toxicity
  • Patient has a history of clinically significant cardiac conditions, including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or New York Heart Association (NYHA) Class III or IV congestive heart failure. Patient must have no clinically significant ECG abnormalities and not have a pacemaker or cardioverter/defibrillator implanted
  • Patient has undergone splenectomy or has any history of autoimmune disorder
  • Patient has received immunosuppressive treatment (e.g., substances or treatments known to diminish immune response such as radiation, antimetabolites, alkylators, antilymphocytic sera, systemic corticosteroids) within 1 month prior to enrollment. Topical hydrocortisone up to a concentration of <=1% will be allowed
  • Patient has known acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections. Patient must also have discontinued aspirin, NSAID, or any therapeutic warfarin or low molecular-weight heparin at least 2 weeks prior to enrollment. Patients on prophylactic anticoagulant therapy such as low dose warfarin or heparin flush for in-dwelling catheters, or low dose, cardiac-protective aspirin may be enrolled providing they meet the coagulation entry parameters following discussion with the SPONSOR
  • The presence of Coombs positive serology at the time of entry
  • Patient has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of study entry
  • Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate
  • Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
  • Patient is pregnant or breastfeeding, or expecting to conceive at any time during the study or within 1 year after receiving the last vaccination. All patients must agree to contraceptive use/abstinence during the study period and non-menopausal women (women who have experienced menses within the past year) must agree to contraception during the time of study participation and for 1 year following the last vaccination with either V934 or V935
  • Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive
  • Patient has known history of Hepatitis B or C or active hepatitis A
  • Patient has muscle group (deltoid, triceps, or thigh) that cannot be accessed with a 1.27 cm (1/2") needle length
  • Patient has been vaccinated for any disease or for prophylaxis within 1 month prior to the first vaccination
  • Patient has any metal implants in the area of the injection site (e.g., shoulder implant, in the upper arms or shoulder girdle)
  • The patient has been diagnosed with Systemic Lupus Erythematosus (SLE) or has a positive ANA titer and 1 of the following: positive anti-double-stranded DNA antibodies, positive anti-Sm antibodies, or low C3 levels. Patients with a positive ANA screen and/or a positive ANA titer only can be admitted to the trial, if in the opinion of the Investigator, the patient does not meet the American College of Rheumatology (ACR) diagnostic criteria for SLE
  • Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753415

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
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
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009