Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors (NCT00003597) | Clinical Trial Compass
CompletedPhase 1
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
United States, Australia16 participantsStarted 1998-11
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.
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.
DISEASE CHARACTERISTICS: Histologically proven (except for brain stem tumors) malignancy that has
failed or relapsed after standard first-line antineoplastic therapy
* Sarcoma (soft tissue and bone)
* Kidney tumors
* Brain tumors
* Other solid tumors (gonadal and germ cell tumors, malignant melanoma,
* retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks
No bone marrow involvement
No prior or concurrent myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Lansky or Karnofsky 60-100%
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1000/mm3
* Platelet count greater than 100,000/mm3
* No grade III or IV thrombosis
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
Renal:
* Creatinine clearance or glomerular filtration rate at least 70 mL/min
Cardiovascular:
* Ejection fraction normal
* No evidence of arrhythmias requiring therapy
* Fractional shortening greater than 28%
Other:
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 10 days since prior colony-stimulating factor therapy and recovered
* At least 30 days since prior epoetin alfa
* No other concurrent cytokines, including epoetin alfa
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and
* recovered
* At least 3 months since therapy with etoposide, car…
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
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)