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

NCT00660231 | Completed Phase 2 DMC

• 4 other identifiers: UCL/06/009CRUK-UCL-GEMBEXEU-20841EUDRACT 2006-000591-33
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of objective response

  at 24 weeks

Secondary Outcomes (2)

• Duration and durability of objective disease response

  up to 5 years after treatment start

• Assessment of quality of life

  up to 5 years after treatment start

Study Arms (1)

GemBex

EXPERIMENTAL

Gemcitabine days 1 and 8 of a 3 week cycle (4 cycles total - 12 weeks) Bexarotene daily: in combination with Gemcitabine during first 12 weeks, then Bexarotene maintenance until disease progression.

Drug: bexarotene; Drug: gemcitabine hydrochloride

Interventions

bexarotene DRUG

Bexarotene daily p.o. 150mg/sq m during week 1 and 2, then 300mg/sq m if tolerated.

Also known as: Targretin

GemBex

gemcitabine hydrochloride DRUG

Gemcitabine i.v. 1000mg/sq m day 1 and day 8 of four 21 day cycles.

GemBex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead

Study Sites (7)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Cornwall Hospital

Truro, England, TR1 3LJ, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Interventions

Bexarotene; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tim Illidge

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 17, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

GB (7)