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Difficulty enrolling subjects
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: | Experimental | Temozolomide plus imatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gleevec | Drug | Gleevec (600 mg) daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Grade 3 or 4 Adverse Events | Number of reported grade 3 or 4 adverse events | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Response | Response rate by RECIST | through study completion, an average of 1 year |
| To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Fecher, MD | Rogel Cancer Center | Principal Investigator |
| tara mitchell, MD | Abramson CC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25252722 | Result | Bajor DL, Xu X, Torigian DA, Mick R, Garcia LR, Richman LP, Desmarais C, Nathanson KL, Schuchter LM, Kalos M, Vonderheide RH. Immune activation and a 9-year ongoing complete remission following CD40 antibody therapy and metastasectomy in a patient with metastatic melanoma. Cancer Immunol Res. 2014 Nov;2(11):1051-8. doi: 10.1158/2326-6066.CIR-14-0154. Epub 2014 Sep 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: | Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: | Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily. |
| 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 | Safety - Grade 3 or 4 Adverse Events | Number of reported grade 3 or 4 adverse events | Data from final 4 patients enrolled on study not available | Posted | Number | Adverse Events | through study completion, an average of 1 year |
|
|
through study completion, an average of 1 year
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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 | Arm A: | Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DVT | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara C Mitchell | Penn | 215-662-4000 | Tara.Mitchell@pennmedicine.upenn.edu |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Temodar | Drug | Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. |
|
|
| through study completion |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Response | Response rate by RECIST | 4 subjects did not meet physician criteria for response rate, thus their data was unusable | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
|
| Secondary | To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide | Not Posted | through study completion | Participants |
| 3 |
| 28 |
| 28 |
| 28 |
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |