A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma
OBJECTIVES:
Primary
- Confirm the feasibility and efficacy of the combination of gemcitabine hydrochloride
and bexarotene in patients with cutaneous T-cell lymphoma whose disease is no longer
controlled by skin-directed therapy and who have had at least one prior systemic
therapy.
Secondary
- Determine the rate of objective disease control as defined by complete response (CR),
clinical complete response (CCR), partial response (PR), and stable disease (SD) for 6
months as determined by the Objective Primary Disease Response Evaluation Criteria
(OPDREC).
- Evaluate the duration and durability of objective disease response (CR, CCR and PR) as
determined by OPDREC criteria.
- Evaluate time to objective disease response.
- Determine the safety of this combination in terms of adverse events, clinical
laboratory data, physical examinations, rate of neutropenic fever and sepsis, blood
transfusions, and treatment compliance.
- Determine the time to objective disease progression.
- Determine the time to treatment failure.
- Determine change from baseline in Severity-Weighted Assessment Tool (SWAT) value,
Erythroderma SWAT value, Pruritus Visual Analogue Scale, and ECOG performance status.
- Determine proportion of disease control, response, and progression as determined by
RECIST criteria.
- Evaluate the proportion of patients with clearing of Sézary cells from the blood and
bone marrow.
- Measure changes in patient assessed Quality of Life using Skindex 29 and EORTC QLQ-30.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral bexarotene daily on
days 1-21. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease
progression or unacceptable toxicity. After 4 courses of study therapy, patients with
responding disease receive oral bexarotene alone daily until disease progression or
treatment no longer tolerated.
Patients complete a quality of life questionnaire at baseline, during study therapy, and
after completion of study treatment.
After completion of study treatment, patients are followed every 2 months for up to 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous T-cell lymphoma (CTCL) including its variants
(e.g., mycosis fungoides and Sézary syndrome)
- CTCL stage IB, IIA, IIB, III or IVA disease
- No visceral involvement (i.e., stage IVB disease)
- Lymphadenopathy is allowed
- Patients must have developed progressive disease after receiving or have been
refractory to at least 1 course of prior standard, systemic, skin-directed therapy
(e.g., interferon, chemotherapy, or denileukin diftitox [Ontak®])
- No CD30 + (Ki1+ve) anaplastic large cell lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 6 months
- Hemoglobin ≥ 9.0 g/dL (transfusions and/or erythropoietin are allowed)
- ANC > 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 2 times ULN
- Serum creatinine ≤ 2 times ULN
- No clinically significant active infection
- No uncontrolled diabetes mellitus
- No excessive alcohol consumption
- No biliary tract disease
- No history of pancreatitis
- HIV negative
- Hepatitis B and C negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study
participation
- No other malignancy within the past 5 years except curatively treated basal or
squamous cell skin cancer, cervical epithelial neoplasm CIN1, or carcinoma in situ
- No other significant medical or psychiatric condition that would preclude study
compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since any prior investigational agent
- More than 2 weeks since prior topical steroids or more than 4 weeks since prior
systemic steroids
- Local radiotherapy may be given to isolated symptomatic tumour nodules that require
immediate treatment for up to 2 weeks prior to study drugs
- No prior treatment with bexarotene (Targretin®)
- No concurrent anticancer therapy
- No concurrent investigational agent
- No concurrent drug therapy with other medications that can elevate triglycerides or
cause pancreatic toxicity (e.g., gemfibrozil)
- No concurrent warfarin
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of objective response
Outcome Time Frame:
at 24 weeks
Safety Issue:
No
Principal Investigator
Tim Illidge
Investigator Role:
Principal Investigator
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Authority
Study ID:
UCL/06/009
NCT ID:
NCT00660231
Start Date:
March 2008
Completion Date:
September 2016
Related Keywords:
- Lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- stage IB mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage IB 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
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
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