Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or R… (NCT00074087) | Clinical Trial Compass
CompletedPhase 2
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Austria, Germany49 participantsStarted 2003-10
Plain-language summary
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 range18 Years – 120 Years
SexALL
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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…
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