DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas (NCT00004212) | Clinical Trial Compass
CompletedPhase 1
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
United StatesStarted 1999-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy.
Who can participate
Age range
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 confirmed advanced solid tumors, including brain tumors and lymphomas, that have failed standard therapy (surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no standard therapy exists
* Histology requirement waived for brain stem gliomas
PATIENT CHARACTERISTICS:
Age:
* 21 and under at diagnosis
Performance status:
* ECOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 750/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 8.5 g/dL
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases)
Renal:
* Creatinine no greater than 1.5 times ULN OR
* GFR at least 70 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No history of severe or life-threatening hypersensitivity to camptothecin analogs
* HIV negative
* No other concurrent severe or uncontrolled medical illness
* No systemic infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Recovered from prior immunotherapy
Chemotherapy:
* See Disease Characteristics
* Recovered from prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior extensive radiotherapy involving cranial, whole pelvic, or at least 25% of bone marrow reserve
* Recovered from prior radiotherapy
* Concurrent localized radi…
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.