Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT00255801 |
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Recruitment Status :
Completed
First Posted : November 21, 2005
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
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RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.
PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by bexarotene works in treating patients with cutaneous T-cell lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: Targretin® (bexarotene) Drug: pegylated liposomal doxorubicin hydrochloride | Phase 2 |
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell lymphoma treated with doxorubicin HCl liposome followed by bexarotene.
Secondary
- Determine the complete and partial response rate in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive doxorubicin HCl liposome IV over 30-90 minutes once on day 1. Treatment repeats every 2 weeks for 8 courses. Beginning within 4 weeks after the last dose of doxorubicin HCl liposome, patients receive oral bexarotene once daily for at least 16 weeks. Patients who achieve a complete or partial response may continue to receive bexarotene in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®) |
| Study Start Date : | November 2005 |
| Actual Primary Completion Date : | October 2017 |
| Actual Study Completion Date : | October 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Doxil and Targretin® (bexarotene)
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
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Drug: Targretin® (bexarotene) Drug: pegylated liposomal doxorubicin hydrochloride |
- Median Progression-free Survival [ Time Frame: 3 years ]
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT
- CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.
- CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.
- Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
- Maximum Therapeutic Response [ Time Frame: 2 years ]
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT
- CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.
- CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.
- Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed cutaneous T-cell lymphoma
- Stage IB-IV disease
- Measurable disease
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Newly diagnosed or previously treated disease
- No demonstrated resistance to prior bexarotene
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
- No New York Heart Association class II-IV heart disease
- No clinical evidence of congestive heart failure
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
- No history of hypersensitivity reactions attributed to doxorubicin HCl liposome or its components
- No active potentially life-threatening infection
- No other acute disease
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
- Prior doxorubicin allowed provided the cumulative dose is ≤ 300 mg/m^2
- Prior epirubicin hydrochloride allowed provided the cumulative dose is ≤ 540 mg/m^2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255801
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Principal Investigator: | David J. Straus, MD | Memorial Sloan Kettering Cancer Center | |
| Principal Investigator: | Steven M. Horwitz, MD | Memorial Sloan Kettering Cancer Center | |
| Principal Investigator: | Patricia L. Myskowski, MD | Memorial Sloan Kettering Cancer Center |
Documents provided by Memorial Sloan Kettering Cancer Center:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00255801 History of Changes |
| Other Study ID Numbers: |
05-098 MSKCC-05098 |
| First Posted: | November 21, 2005 Key Record Dates |
| Results First Posted: | August 16, 2018 |
| Last Update Posted: | August 16, 2018 |
| Last Verified: | July 2018 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Doxorubicin |
Liposomal doxorubicin Bexarotene Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |