|
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides Clinical research trials and Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides. Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides clinical trial. Test subjects typically receive the most expert healthcare available for their Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "L" Clinical Trials Conditions > Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides  Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
For Condition: stage 2 mycosis fungoides/Sezary syndrome,stage 4 mycosis fungoides/Sezary syndrome,recurrent mycosis fungoides/Sezary syndrome,recurrent cutaneous T-cell lymphoma,stage 2 cutaneous T-cell lymphoma,stage 4 cutaneous T-cell lymphoma
Status: Recruiting
Sponsor(s): EORTC Cutaneous Lymphoma Task Force ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as liposomaldoxorubicin, 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 refractorymycosis fungoides.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ReinhardDummer, , UniversitaetsSpital
UniversitaetsSpital *Recruiting*
Zurich, , CH-8091
Switzerland
Recruiting Contact Person 41-1-255-1111
Additional Information:
Study ID Numbers: CDR0000341686; EORTC-21012
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074087
Other Stage 2 Cutaneous T-Cell Lymphoma Studies:
1. Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
2. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
3. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
4. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
Related Studies:
Other stage 2 cutaneous T-cell lymphoma Clinical Trials
Other Clinical Trials
Other Zurich Clinical Trials
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
|
|
|
|
|
|
|
|
