A Phase 1/2 interventional study of Gleevec and Temodar in Melanoma and Advanced Melanoma, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1/2, Interventional, and Treatment
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 32 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Temozolomide plus imatinib
Drug: Gleevec · Drug: Temodar
Safety - Grade 3 or 4 Adverse Events
Number of reported grade 3 or 4 adverse events
Time frame: through study completion, an average of 1 year
Response
Response rate by RECIST
Time frame: 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
Time frame: through study completion
| Milestone | Arm A: |
|---|---|
| Started | 32 |
| Completed | 28 |
| Not completed | 4 |
Number of reported grade 3 or 4 adverse events
| Adverse Events | Arm A: |
|---|---|
| Safety - Grade 3 or 4 Adverse Events | 20 |
Response rate by RECIST
| Participants | Arm A: |
|---|---|
| Response | 1 |
Results for this outcome have not been posted.
Collected over through study completion, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: | — | 3/28 (10.7%) | 28/28 (100%) |
| Event | Arm A: |
|---|---|
| DVTVascular disorders | 1/28 |
| Pericardial effusionCardiac disorders | 1/28 |
| HemothoraxRespiratory, thoracic and mediastinal disorders | 1/28 |
| Event | Arm A: |
|---|---|
| FatigueGeneral disorders | 16/28 |
| DiarrheaGastrointestinal disorders | 10/28 |
| AnemiaBlood and lymphatic system disorders | 8/28 |
| ThrombocytopeniaBlood and lymphatic system disorders | 7/28 |
| Age, Categorical(Participants) | Arm A: |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 10 |
| Sex: Female, Male(Participants) | Arm A: |
|---|---|
| Female | 15 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | Arm A: |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 31 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Arm A: |
|---|---|
| United States | 32 |
The record gives a start of Jan 2003, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2023, 12 years after primary completion. A results delay was requested in Apr 2020.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Imatinib · Temozolomide
Abramson Cancer Center at Penn Medicine →