Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: pegylated liposomal doxorubicin hydrochloride

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00074087

EORTC-21012

2004-001746-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

49 participants in 1 patient group

Caelyx

Experimental group

Description:

doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses.

Treatment:

Drug: pegylated liposomal doxorubicin hydrochloride