Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma (NCT00363272) | Clinical Trial Compass
CompletedPhase 1
Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma
United States30 participantsStarted 2006-06
Plain-language summary
This phase I trial is studying the side effects and best dose of ispinesib in treating young patients with relapsed or refractory solid tumors or lymphoma. Drugs used in chemotherapy, such as ispinesib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
Who can participate
Age range
1 Year – 21 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 malignancy at either original diagnosis or relapse, including the following:
* Solid tumor, including primary CNS tumors
* Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week
* Patients with CNS tumors must be on stable or decreasing doses of dexamethasone for the past 7 days
* Histology requirement waived for intrinsic brain stem tumors
* Lymphoma
* Measurable or evaluable disease
* No known curative therapy or no therapy proven to prolong survival with an acceptable quality of life exists
* Patients with known bone marrow metastases are eligible for study but are not evaluable for hematologic toxicity
* Not known to be refractory to red blood cell or platelet transfusions
* Karnofsky performance score (PS) 60-100% (\> 10 years of age) or Lansky PS 60-100% (≤ 10 years of age)
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to study enrollment)
* Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows:
* No greater than 0.8 mg/dL (≤ 5 years of age)
* No greater than 1.0 mg/dL (6 to 10 years of age)
* No greater than 1.2 mg/dL (11 to 15 years of age)
* No greater than 1.5 mg/dL (\> 15 years of age)
* Bilirubin ≤ 1.5 times upper li…
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, defined as the maximum dose at which fewer than one-third of patients experience DLT, graded according to NCI CTCAE version 3.0