Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer (NCT00104923) | Clinical Trial Compass
CompletedPhase 1
Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer
United States29 participantsStarted 2005-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fenretinide in a different way may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intravenous fenretinide in treating patients with refractory or relapsed hematologic cancer.
Who can participate
Age range
18 Years – 120 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 or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
* Non-Hodgkin's lymphoma (NHL)
* Hodgkin's lymphoma
* Multiple myeloma
* Acute lymphoblastic leukemia
* Acute myeloid leukemia
* Chronic hematologic malignancy with a poor prognosis (e.g., failed 3 prior standard therapies), including any of the following:
* Chronic lymphocytic leukemia
* Chronic myelogenous leukemia
* Indolent NHL
* Myeloproliferative disorders
* Refractory or relapsed disease, as defined by 1 of the following:
* Resistant to standard therapy for refractory or relapsed disease
* Progressed after standard therapy for advanced disease
* No effective treatment exists
* Measurable or evaluable disease
* No active CNS disease
* Previously treated leptomeningeal disease or brain metastases allowed provided there is no evidence of remaining cancer by positron-emission tomography, MRI, or spinal fluid cytology
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3 (unless due to bone marrow involvement of disease)
* Platelet count ≥ 75,000/mm\^3 (unless due to bone marrow involvement of disease)
* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
* No coagulation disorders
Hepatic
* AST and ALT \< 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastasis)
* Bil…
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
To determine the maximum tolerated dose of fenretinide
Timeframe: participants will be followed for the duration of cycle 1, which is expected to be 3 weeks.
2
To describe the toxicities of fenretinide
Timeframe: participants will be followed for the duration of treatment, which is expected to be 18 weeks or less