CompletedPhase 1

FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia

United States30 participantsStarted 2002-09

Plain-language summary

This phase I trial is studying the side effects and best dose of FR901228 in treating children with refractory or recurrent solid tumors or leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

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.

Inclusion Criteria: * Histologically confirmed malignancy * Extracranial solid tumors or brain tumors\* * Diagnosis of leukemia allowed after maximum tolerated dose is determined, including any of the following: * Acute lymphoblastic leukemia * Acute myelogenous leukemia * Chronic myelogenous leukemia in blast crisis * Disease must be refractory to conventional therapy or no effective conventional therapy exists * CNS tumors resulting in neurological deficits must be stable for 2 weeks before study entry * Performance status - Karnofsky 60-100% (over 10 years old) * Performance status - Lansky 60-100% (10 years old and under) * At least 8 weeks * Absolute neutrophil count at least 1,000/mm\^3 (for solid tumor patients without bone marrow involvement) * Platelet count at least 100,000/mm\^3 (for solid tumor patients without bone marrow involvement; platelet transfusion independent) OR 20,000/mm\^3 (for leukemia patients; platelet transfusion allowed) * Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 5 times ULN * Albumin at least 2 g/dL * Glomerular filtration rate at least 70 mL/min * Creatinine based on age as follows: * No greater than 0.8 mg/dL (for patients 5 years of age and under) * No greater than 1.0 mg/dL (for patients 6 to 10 years of age) * No greater than 1.2 mg/dL (for patients 11 to 15 years of age) * No greater than 1.5 mg/dL (for patients…

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

MTD, defined as that dose at which fewer than one-third of patients experience DLT, graded according to the NCI CTC version 2.0

Timeframe: Up to 28 days

Trial details

NCT IDNCT00053963

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2006-02

View on ClinicalTrials.gov More Blastic Phase Chronic Myelogenous Leukemia trials

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.