NCT00074087

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Oct 2003

Typical duration for phase_2 lymphoma

Geographic Reach
6 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

December 10, 2003

Last Update Submit

July 6, 2018

Conditions

Lymphoma

Keywords

stage II mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromestage IV cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (3)

  • 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

  • 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

  • Toxicity assessed by CTC v.2.0 at the end of each course

Study Arms (1)

Caelyx

EXPERIMENTAL

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

Drug: pegylated liposomal doxorubicin hydrochloride

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG
Caelyx

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Location

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Klinikum der Friedrich-Schiller Universitaet Jena

Jena, D-07740, Germany

Location

Klinikum der Stadt Mannheim

Mannheim, D-68135, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Julius Maximilians Universitaet Hospital

Würzburg, D-97080, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Universita di Torino

Turin, 10126, Italy

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

St. Thomas' Hospital

London, England, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23045580DERIVED

MeSH Terms

Conditions

LymphomaMycosis FungoidesSezary SyndromeLymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Study Officials

  • Reinhard Dummer, MD

    UniversitaetsSpital Zuerich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

October 1, 2003

Primary Completion

July 1, 2009

Study Completion

September 1, 2010

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations

IT(1)CH(1)GB(1)DE(5)IL(1)AU(2)