Clinical trial NCT00074087: Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Official title: Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage II mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-12-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

Primary

* Determine the antitumor activity of doxorubicin HCl liposome, in terms of response rate (complete response and partial response), in patients with stage IIB, IVA, or IVB recurrent or refractory mycosis fungoides.

Secondary

* Determine the time to progression and duration of response in patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity or until a maximum cumulative anthracycline(s) dose of 400 mg/m\^2 has been reached (including anthracyclines from prior treatment).

Patients are followed every 12 weeks until disease progression.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1 year.

Eligibility criteria: 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 therapy

* See Disease Characteristics
* More than 2 weeks since prior immunotherapy

Chemotherapy

* See Disease Characteristics
* Prior systemic chemotherapy allowed provided all of the following conditions are met:

  * Cumulative anthracycline dose is less than 200 mg/m\^2
  * No allergy to anthracyclines
  * Prior methotrexate is low dose (i.e., weekly dose less than 30 mg)
* More than 2 weeks since prior chemotherapy

Endocrine therapy

* See Disease Characteristics
* No concurrent systemic steroids

Radiotherapy

* More than 2 weeks since prior radiotherapy

Surgery

* Not specified

Other

* Recovered from toxic effects of prior therapy, excluding alopecia
* No other concurrent anticancer therapy

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Time to progression measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment
measure: Duration of response measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment and then every 12 weeks until progression
measure: Toxicity assessed by CTC v.2.0 at the end of each course
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Karl-Franzens-University Graz
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus - Universitatskliniken
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller Universitaet Jena
city: Mannheim
country: Germany
facility: Klinikum der Stadt Mannheim
city: Minden
country: Germany
facility: Klinikum Minden
city: Wuerzburg
country: Germany
facility: Julius Maximilians Universitaet Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Turin
country: Italy
facility: Universita di Torino
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich
city: London
country: United Kingdom
facility: St. Thomas' Hospital
state: England
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Reinhard Dummer, MD
role: STUDY_CHAIR
References:
citation: Dummer R, Quaglino P, Becker JC, Hasan B, Karrasch M, Whittaker S, Morris S, Weichenthal M, Stadler R, Bagot M, Cozzio A, Bernengo MG, Knobler R. Prospective international multicenter phase II trial of intravenous pegylated liposomal doxorubicin monochemotherapy in patients with stage IIB, IVA, or IVB advanced mycosis fungoides: final results from EORTC 21012. J Clin Oncol. 2012 Nov 20;30(33):4091-7. doi: 10.1200/JCO.2011.39.8065. Epub 2012 Oct 8.