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

Sponsor:	European Organization for Research and Treatment of Cancer - EORTC
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00074087

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Drug: pegylated liposomal doxorubicin hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Toxicity assessed by CTC v.2.0 at the end of each course [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	October 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074087

Locations

Austria
Karl-Franzens-University Graz
Graz, Austria, A-8010
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, Germany, D-07740
Klinikum der Stadt Mannheim
Mannheim, Germany, D-68135
Klinikum Minden
Minden, Germany, D-32423
Julius Maximilians Universitaet Hospital
Wuerzburg, Germany, D-97080
Israel
Rambam Medical Center
Haifa, Israel, 31096
Italy
Universita di Torino
Turin, Italy, 10126
Switzerland
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
United Kingdom
St. Thomas' Hospital
London, England, United Kingdom, SE1 9RT

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer - EORTC

Investigators

Investigator:

Reinhard Dummer, MD

UniversitaetsSpital Zuerich

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00074087 History of Changes
Other Study ID Numbers:	CDR0000341686, EORTC-21012, EUDRACT-2004-001746-32
Study First Received:	December 10, 2003
Last Updated:	November 26, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Lymphoma
Mycoses
Mycosis Fungoides
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012