Melanoma, Advanced Melanoma
Conditions
Keywords
Temzolomide, Gleevec, Melanoma, Advanced melanoma, Phase II
Brief summary
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.
Interventions
Sponsors
Novartis Pharmaceuticals
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide * Measurable disease * Performance status \<= 2 * Life expectancy greater than 3 months
Exclusion criteria
* No prior treatment with temozolomide or imatinib mesylate * Organ allografts * Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area * Pregnancy or lactation * History of second cancer * Known hypersensitivity to temozolomide or imatinib * Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Grade 3 or 4 Adverse Events | through study completion, an average of 1 year | Number of reported grade 3 or 4 adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response | through study completion, an average of 1 year | Response rate by RECIST |
| To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide | through study completion | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Arm A: |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 28 |
| serious Total, serious adverse events | 3 / 28 |
Outcome results
Primary
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
Population: Data from final 4 patients enrolled on study not available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: | Safety - Grade 3 or 4 Adverse Events | 20 Adverse Events |
Secondary
Response
Response rate by RECIST
Time frame: through study completion, an average of 1 year
Population: 4 subjects did not meet physician criteria for response rate, thus their data was unusable
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: | Response | 1 Participants |
Secondary
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