Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
This study is ongoing, but not recruiting participants.
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00074087
First received: December 10, 2003
Last updated: January 7, 2013
Last verified: January 2013
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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 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment 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:
Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:
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 ]
| Enrollment: | 49 |
| Study Start Date: | October 2003 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Caelyx
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 |
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 Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Reinhard Dummer, MD | UniversitaetsSpital Zuerich |
More Information
Additional Information:
No publications provided by European Organisation for Research and Treatment of Cancer - EORTC
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00074087 History of Changes |
| Other Study ID Numbers: | EORTC-21012, 2004-001746-32 |
| Study First Received: | December 10, 2003 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
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 June 17, 2013