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- Ensaio Clínico NCT00667017
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.
Visão geral do estudo
Status
Condições
Descrição detalhada
OBJECTIVES:
Primary
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .
Secondary
- Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
- Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.
OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5. Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected at baseline, and during study for CD25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Texas
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Dallas, Texas, Estados Unidos, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL)
Relapsed or refractory disease, meeting 1 of the following criteria:
- Progression of disease following 2 prior chemotherapies
- Failure to respond to the second prior chemotherapy
- Measurable disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Serum creatinine < 1.5 times upper limit of normal (ULN)
- Serum AST/ALT < 2.5 times ULN
- Total bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL in patients with Gilbert syndrome)
- WBC count ≥ 3,000/mm³
- Platelet count ≥ 100,000/mm³
- Serum albumin > 2.5 g/dL
- LVEF ≥ 45% by 2-D ECHO or MUGA scan
- Human antimurine antibody < 1 μg/mL
- Patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test)
- Must be willing to undergo venipuncture and central line placement
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HBV surface antigen, HCV, or HIV antibody positivity
- No autoimmune disease or immunodeficiency (i.e., HIV)
No history of uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia)
- Psychiatric illness and/or social situation that would preclude study compliance
- No other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior systemic therapy for CTCL
- More than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy
- No prior therapy with anti-CD25 immunotoxin IMTOX25 and/or Ontak
- No other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: IMTOX25 at 2mg/m²/dose
Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses.
A total of 6 cycles of treatment will be allowed.
A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Response Rate - Cutaneous T Cell Lymphoma (CTCL)
Prazo: Once a week for seven weeks
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Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
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Once a week for seven weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Simrit Parmar, MD, Simmons Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SCCC-02407
- CDR0000594170 (Identificador de registro: PDQ (Physician Data Query))
- SCCC-122007-014
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