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
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:	Treatment, Open Label
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 Myocet

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
Allgemeines Krankenhaus - Universitatskliniken	Recruiting
Vienna, Austria, A-1090
Contact: Contact Person 43-1-40-400
Karl-Franzens-University Graz	Recruiting
Graz, Austria, A-8010
Contact: Contact Person 43-316-380-4100
Germany
Julius Maximilians Universitaet Hospital	Recruiting
Wuerzburg, Germany, D-97080
Contact: Contact Person 49-9-312-012-3756
Klinikum der Friedrich-Schiller Universitaet Jena	Recruiting
Jena, Germany, D-07740
Contact: Contact Person 49-3641-933-114
Klinikum der Stadt Mannheim	Recruiting
Mannheim, Germany, D-68135
Contact: Contact Person 49-621-383-3833
Klinikum Minden	Recruiting
Minden, Germany, D-32423
Contact: Contact Person 49-571-801-4810
Universitaetsklinikum Essen	Recruiting
Essen, Germany, D-45122
Contact: Contact Person 49-201-723-2321
Israel
Rambam Medical Center	Recruiting
Haifa, Israel, 31096
Contact: Contact Person 972-4-854-3003
Italy
Universita di Torino	Recruiting
Turin, Italy, 10126
Contact: Contact Person 39-011-670-5955
Switzerland
UniversitaetsSpital Zuerich	Recruiting
Zurich, Switzerland, CH-8091
Contact: Contact Person 41-1-255-1111
United Kingdom, England
St. Thomas' Hospital	Recruiting
London, England, United Kingdom, SE1 9RT
Contact: Contact Person 44-171-922-8009

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

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

Study ID Numbers:	CDR0000341686, EORTC-21012, EUDRACT-2004-001746-32
Study First Received:	December 10, 2003
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00074087 History of Changes
Health Authority:	Unspecified

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:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Mycosis Fungoides
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Mycoses

Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on November 27, 2009