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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006516 | U.S. NIH Grant/Contract | View source | |
| VALENTIS-DFCI-99081 | |||
| NCI-G99-1578 | |||
| CDR0000067274 | Other Identifier | Other |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.
This is a Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-12 Injection 3mg/ml [Phase I] | Experimental | The dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period. |
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| IL-12 Injection 6mg/ml [Phase I] | Experimental | The dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period. |
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| IL-12 Injection MTD [Phase II] | Experimental | The dosing schedule will consist of eight injections over a seven week period of formulated plasmid at the MTD established in the phase I portion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-12 | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) [Phase I] | The MTD of IL-12 gene medicine is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed in the two dose levels planned then evaluation of a third escalation will be considered. If the MTD is not reached, the dose selected for use in the phase II portion will be defined as the maximum volume that can be reasonably and safely injected into the tumor. | Assessed during therapy up to 7 weeks. |
| Dose Limiting Toxicity (DLT) [Phase I] | A DLT was defined as grade 4 hematologic toxicity greater than 5 days duration or grade 3 or higher non-hematologic toxicity based on NCI common toxicity criteria (CTCAEv2). | Assessed during therapy up to 7 weeks. |
| Grade 3-4 Toxicity Rate [Phase II] | All Grade 3-4 events based on CTCAEv2 as reported on case report forms. | Assessed until last scheduled on-study visit up to visit 12/day 112. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progressive Disease (TTP) [Phase III] | Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). | Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A. Dimitrios Colevas, MD | NCI-Investigational Drug Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D018664 | Interleukin-12 |
| D053765 | Interleukin-12 Subunit p35 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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This is a non-randomize phase I/II where patients are directly assigned treatment.
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| Response [Phase II] | Best response on treatment classifies patients into 4 groups: complete response (CR) is complete disappearance of all signs, symptoms, biochemical and radiographic evidence of tumor for a minimum of 1 month; partial response (PR) is >/=50% decreases in tumor area for at least 4 weeks without an increase in size of other lesions of >25% or appearance of new lesions; progressive disease (PD) is >50% increase in size of any lesion present at baseline or after response, or appearance of a new lesion; and stable disease (SD) is neither PR or better nor PD. | Measurement by CT occurs up to visit 12/day 112. |
| Overall Survival (OS) [Phase II] | OS is defined as the duration of time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods. | Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient. |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |