Sodium Stibogluconate and IFNa-2b Followed By CDDP, VLB and DTIC Treating Pts.With Advanced Melan… (NCT00498979) | Clinical Trial Compass
CompletedPhase 1
Sodium Stibogluconate and IFNa-2b Followed By CDDP, VLB and DTIC Treating Pts.With Advanced Melanoma or Other Cancers
United States22 participantsStarted 2007-05
Plain-language summary
RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as cisplatin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sodium stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and dacarbazine in treating patients with advanced melanoma or other cancer.
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.
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma or other malignancies
* Must be refractory or resistant to established treatments OR have metastatic disease for which no effective therapy has been established
* Gliomas or controlled CNS metastasis allowed
* A CT scan or MRI must confirm stable brain metastases within 28 days of study entry
* Patients with primary CNS malignancies refractory to other therapies are eligible
* Malignancy potentially responsive to sodium stibogluconate and/or interferon alfa-2b and combination chemotherapy
* Patients must have measurable or evaluable disease
* Evaluable disease can include clinically or radiographically nonmeasurable tumor, specific tumor markers, or stage IV patients with no evidence of disease (NED)
PATIENT CHARACTERISTICS:
* Inclusion criteria:
* ECOG performance status 0-2
* Granulocytes \> 1,500/μl
* Platelets \> 100,000/μl
* Creatinine \< 1.5 x upper limit of normal (ULN)
* Bilirubin \< 1.5 x ULN
* AST and ALT \< 1.5 x ULN (unless due to hepatic metastases)
* Potassium ≤ 5.0 mmol/L
* Magnesium ≤ 2.4 mg/dL
* Creatinine clearance ≥ 60 cc/min
* Ejection fraction ≥ 50%
* Exclusion criteria:
* Pregnant or lactating women and fertile women or men unless surgically sterile or using effective contraception
* All female patients of childbearing potential or less than 1 year postmenopausal must have a negative β-HCG pregnancy test at baseline and practice a medically accep…
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
Safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy