RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis fungoides.
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 confirmed mycosis fungoides
* Stage IIB, IVA, or IVB
* Refractory or recurrent disease after at least 2 of the following prior therapies:
* Local and/or systemic steroids
* Retinoids
* Interferon alfa
* Local carmustine
* Systemic chemotherapy
* Psoralen and ultraviolet A (PUVA) light therapy
* No CNS involvement
* No erythroderma (T4)
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 1,500/mm\^3
* WBC at least 2,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2.5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* LVEF normal by echocardiography or radionuclide angiocardiography
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 years after study participation
* No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up
* No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy)
* No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic ther…
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
Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression
Trial details
NCT IDNCT00074087
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC