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The study was stopped due to slow rate of recruitment.
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| Name | Class |
|---|---|
| Stanford University | OTHER |
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This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VTX-2337 plus radiation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VTX-2337 plus radiotherapy | Drug | Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation. | Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response. | Tumor assessment conducted at 12 weeks and every 3-6 months thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Safety and Feasibility of the Combination Regimen. | Safety assessed throughout study period. |
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Major Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amar Patel, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VTX-2337 Plus Radiation | Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VTX-2337 Plus Radiation | VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation. | Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response. | Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint). | Posted | Number | participants | Tumor assessment conducted at 12 weeks and every 3-6 months thereafter |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VTX-2337 Plus Radiation | VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site reaction | General disorders | Systematic Assessment |
Due to slow enrollment, the study was closed by the sponsor. 2 participants were enrolled. 1 participant was analyzed for the primary outcome measure (tumor response) and 2 participants were analyzed for safety and toxicity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristi Manjarrez, Vice President, Clinical Affairs | VentiRx Pharmaceuticals Inc. | 206-689-2259 | kmanjarrez@ventirx.com |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C573973 | VTX-2337 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | Assess the Safety and Feasibility of the Combination Regimen. | Not Posted | Safety assessed throughout study period. | Participants |
| 0 |
| 2 |
| 2 |
| 2 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
|
| flu like symptoms | General disorders | Systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| pain | General disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| edema - limb | General disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| hypotension | Vascular disorders | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |