Gemcitabine and Bexarotene in Treating Patients With Progressive or Refractory Stage IB, Stage II, Stage III, or Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see how well it works in treating patients with progressive or refractory stage IB, stage II, stage III, or stage IV cutaneous T-cell non-Hodgkin lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Bexarotene; Gemcitabine

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