Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma (NCT01005472) | Clinical Trial Compass
CompletedPhase 1
Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma
United States16 participantsStarted 2008-12-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.
Phase II was never conducted due to toxicity in phase I.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed Stage IIIC unresectable cutaneous or mucosal melanoma with measureable disease or stage IV cutaneous, mucosal or ocular melanoma with measureable disease.
* ECOG performance status of 0-2
* age greater than or equal to 18 years
* ANC ≥ 1,500/µL
* Platelet count ≥ 100,000/µL
* Hemoglobin ≥ 10.0 g/dL
* Creatinine ≤ 2 times upper limit of normal (ULN)
* Total bilirubin ≤ 2 times ULN
* LDH ≤ 5 times ULN
* AST or ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
* LVEF ≥ 50% on screening ECHO
* women of childbearing potential must have a negative urine or serum pregnancy test upto 28 days prior to commencement of dosing.
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* before study entry , written informed consent must be obtained. Written informed consent must be obtained from patient prior to performing any study related procedures.
Exclusion Criteria
* pregnant or nursing
* any following within the past 12 months:
* Myocardial infarction
* Severe and/or unstable angina
* Coronary and/or peripheral artery bypass graft
* Symptomatic congestive heart failure
* Cerebrovascular accident or transient ischemic attack
* Pulmonary embolism
* ongoing cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
* prolonged QTc interval on baselin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I)
Timeframe: 6 weeks
2
Overall safety
Timeframe: 5 years
3
Response rate as assessed by modified RECIST criteria (phase II)