- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261404
TNFerade™ Biologic Plus Radiation for Metastatic Melanoma
May 11, 2011 updated by: GenVec
A Phase II, Open Label, Single Arm, "Proof of Concept" Study of TNFerade™ Plus Radiation in Patients With Metastatic Melanoma
Phase II, open label study in which patients with metastatic melanoma (stage III or IV) who have cancer which is not considered curable by surgery will receive intratumoral injections of TNFerade™ plus radiation as a 4-week treatment, followed by a 3 year follow-up period.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75201
- Mary Crowley Medical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient must be 18 years old or older, and able to give informed consent.
- Patients with metastatic melanoma (AJCC stage III or IV) who are not eligible for curative surgery and who are candidates for experimental therapy. Eligible patients will include those with melanoma involving the regional lymph nodes and surrounding tissues as well as those with unresectable cutaneous, subcutaneous, nodal or soft tissue metastases.
- Patients must have one or more tumor nodules accessible for direct injection.
- Patients with metastases outside the treatment field may be enrolled if the sites of metastases do not limit survival expectancy to less than 3 months.
- Patients must be unlikely to derive significant potential benefit from other treatment options and no other treatments should be anticipated during the study treatment period or a period of two months thereafter.
- Patient's Karnofsky performance status must be greater than or equal to 70%.
Exclusion Criteria:
- Chemotherapy or experimental medications within the last four weeks prior to Day 1.
- Active disease of the central nervous system.
- Baseline liver enzymes (AST, ALT, bilirubin, alkaline phosphatase) greater than 3 times the upper limit normal.
- Renal insufficiency (Serum creatinine greater than 2.0 mg/dL).
- Coagulopathy (PT INR >1.5 or PTT ratio >1.5 in patients not receiving anticoagulants).
- Significant anemia (e.g. hematocrit <28% or hemoglobin <9 g/dL). May have RBC transfusion, or thrombocytopenia (platelet count less than 100,000/μl); or leukopenia (WBC <3000/μl; ANC <1500/μl).
- Patients with documented history of deep venous thrombosis, pulmonary embolus, cerebrovascular disease, stroke, or TIA.
- Patients with history of coagulopathy or known thrombophillic disorders.
- Clinical evidence of active infection of any type, including hepatitis B or C virus.
- Pregnant or lactating women. It is recommended that both men and women use condoms or another barrier method of birth control for at least 2 months following the last administration of TNFerade™ biologic and some form of birth control for at least 1 year.
- Significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial
- Chronic systemic corticosteroid use, orally or parenterally administered.
- Known sensitivity to lidocaine, procaine or amide local anesthetics (used for topical anesthesia).
- Surgery within the last 4 weeks prior to day 1 (if patient was ambulatory within 48 hours of surgery, patient may be considered eligible)
- Attempted resection of the tumor to be treated, or surgery on the area to be treated, with incomplete healing of surgical wound. (If the surgical wounds are completely healed and lesion continues to progress, patient may be enrolled.)
- Patients with a history of clinical lymphedema in the area to be treated.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 2, 2005
First Submitted That Met QC Criteria
December 2, 2005
First Posted (Estimate)
December 5, 2005
Study Record Updates
Last Update Posted (Estimate)
May 12, 2011
Last Update Submitted That Met QC Criteria
May 11, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GV-001.008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
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H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
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MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
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Viewpoint Molecular TargetingRecruitingMetastatic Melanoma | Melanoma (Skin) | Mucosal Melanoma | Melanoma Stage IV | Melanoma Stage III | Melanoma, UvealUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
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BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on TNFerade™
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GenVecNational Institutes of Health (NIH)UnknownLocally Advanced Prostate CancerUnited States
-
GenVecCompleted
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GenVecCompleted
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GenVecCompletedEsophageal CancerUnited States
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GenVecCompletedHead and Neck Cancer | Head and Neck NeoplasmsUnited States
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GenVecCompletedHead and Neck Cancer | Head and Neck NeoplasmsUnited States
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BaroNova, Inc.Completed
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London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive MedicalUnknownBrain Damage, Chronic | Cerebellar Cognitive Affective Syndrome | Cerebellar Mutism
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Asklepios Kliniken Hamburg GmbHUniversity of KielCompletedAirway Management | Laryngeal Mask Airway | Fibreoptic Intubation
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive MedicalUnknownTemporal Lobe Epilepsy