Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or … (NCT00303940) | Clinical Trial Compass
CompletedPhase 1
Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors
United States26 participantsStarted 2005-12
Plain-language summary
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when given together with temozolomide or carboplatin in treating young patients with relapsed or refractory brain tumors or other solid tumors.
Who can participate
Age range
2 Years – 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 solid tumors, including, but not limited to, any of the following:
* Rhabdomyosarcoma and other soft tissue sarcomas
* Ewing's sarcoma family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumors
* In patients with brainstem or optic gliomas, requirement for histological confirmation can be waived if biopsy was not performed
* Patients with brainstem gliomas that did not respond to therapy but that are without radiographic evidence of disease progression must have clinical evidence of progression
* Patients with brain tumors must be on stable or tapering dose of corticosteroids for 7 days prior to study entry
* Measurable or evaluable disease
* Relapsed or failed to respond to frontline curative therapy, including any of the following:
* Surgery
* Radiotherapy
* Chemotherapy
* Combination of modalities
* No other potentially curative treatment options available
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8 mg/dL
* Platelet count ≥ 100,000/mm\^3 (platelet transfusion independent)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGPT ≤ 2.5 times ULN
* Creatinine clearance ≥ 60 mL/min OR age-adjusted creatinine\* as follows:
* No more than 0.8 mg/dL (for patients ≤ 5 years of age)
* No more than 1.0 mg/dL (for patients 6 to 10 years of age)
* No…
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.
Trial details
NCT IDNCT00303940
SponsorNational Institutes of Health Clinical Center (CC)