- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00361088
A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma
A Dose Escalation of Zarnestra (R115777) Combined With Velcade® (PS-341) in Patients With Relapsed Multiple Myeloma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In Phase I, patients will receive intravenous PS-341 (Velcade) and 3 different dose levels of oral R115777 (Zarnestra). Dose Limiting Toxicity (DLT) will be determined over a period of one cycle and dose escalation to the next level will not occur until all patients projected at each level complete one cycle of therapy. Once DLT is determined, patients in Phase I and all patients enrolled for the phase II component will be treated at the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue beyond 8 cycles if there is evidence of continued response. The study regimen will consist of two weeks of treatment followed by one week off for a total cycle duration of three weeks. If disease stabilization occurs (noted on 2 consecutive cycles) after the standard 8 cycles are given, treatment will be discontinued.
Patients are to be monitored for adverse events throughout the treatment phases and for a minimum of 30 days after their last dose of drugs. Follow up will include history and physical exam with laboratory evaluation at least every 3 months. Laboratories will include CMP, CBC, SPEP, UPEP, and quantitative immunoglobulins. A skeletal survey will be performed at least every 6 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Florida
-
Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center & Research Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Voluntary written informed consent
- Female subject is either post-menopausal/surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Diagnosis of stage II or III multiple myeloma and have relapsed after at least one prior therapies confirmed by the presence of:
- A new lytic lesion
- A 25% increase in urine or serum monoclonal protein
- Patient can have received PS-341 (Velcade) previously and does not require a previous response.
Patients must have measurable disease. One or more of the following must be present to qualify for this study:
- Serum M-component greater than or equal to 1.0 gm/dl (10.0 g/L) by serum protein electrophoresis
- Urine M-protein excretion > 200 mg/24 (0.2 g/24h) hours, by urine protein electrophoresis
- Abnormal serum free light chain ratio with elevated Kappa or Lambda light chains in serum
- Baseline measurements must be done within 21 days of study entry.
- Karnofsky Performance Status Scale > 60.
- Greater than or equal to 18 years of age.
- Expected survival of greater than 8 weeks.
- Swallow intact study medication tablets.
- Can follow directions or has a caregiver who will be responsible for administering study medication.
Exclusion Criteria:
- Previously treated with R115777 (Zarnestra).
- Undergone an allogeneic bone marrow transplant.
- A platelet count of <100,000 x 10 to the 9 power/L within 14 days before enrollment.
- Absolute neutrophil count of <1.0 x 10 to the 9 power/L within 14 days before enrollment.
- Measured creatinine > 1.5 X the upper limits of normal within 14 days before enrollment.
- Greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
- Hypersensitivity to bortezomib, boron, mannitol or imidazole compounds
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening.
- Received other investigational drugs within 14 days of enrollment or immunotherapy within 30 days of enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Ongoing radiation therapy or radiation therapy within 14 days prior to first treatment.
- Cytotoxic chemotherapy within 30 days prior to first treatment.
- Therapy with high-dose corticosteroids within 14 days prior to first treatment.
Presence of any of the following excludes a patient from entering the study until such condition is resolved (determined within 14 days prior to the first treatment):
- Elevated total bilirubin > 2mg/dl, or direct bilirubin > 2 times the ULN.
- Serum glutamic oxaloacetic transaminase (AST, formerly SGOT) or serum glutamic pyruvic transaminase (ALT, formerly SGPT) > 2 times the ULN
- Serum calcium > 12 mg/dL.
- Concurrent serious infection.
- Life-threatening illness (unrelated to tumor).
- History of any other ACTIVE and INVASIVE cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
Prohibited/allowable medications or precautions:
- Enzyme-inducing anti-epileptic medications (e.g. phenytoin, phenobarbital, carbamazepine) are not allowed.
- Non-enzyme anti-epileptic medications will be allowed.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Fase I
|
Phase I and II: 1.3mg/m2 iv days 1,4,8,11
Outros nomes:
Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3. Phase II: Maximum Tolerated Dose (MTD)
Outros nomes:
|
Experimental: Phase II
|
Phase I and II: 1.3mg/m2 iv days 1,4,8,11
Outros nomes:
Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3. Phase II: Maximum Tolerated Dose (MTD)
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Dose Limiting Toxicity (DLT)
Prazo: Average of 6 months
|
Determine the dose limiting toxicity at 3 weeks post treatment
|
Average of 6 months
|
Maximum Tolerated Dose
Prazo: Average of 6 months
|
Determine the maximum tolerated dose
|
Average of 6 months
|
Response Rates
Prazo: Average of 6 months
|
Determine response rates after 8 cycles of treatment
|
Average of 6 months
|
Toxicity
Prazo: Average of 6 months
|
Determine toxicity profiles
|
Average of 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression Free Survival
Prazo: Average of 12 months
|
Determine progression free survival
|
Average of 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Melissa Alsina, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
- Doenças cardiovasculares
- Doenças Vasculares
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Doenças Hematológicas
- Distúrbios hemorrágicos
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Mieloma múltiplo
- Neoplasias de Células Plasmáticas
- Agentes Antineoplásicos
- Bortezomibe
- Tipifarnibe
Outros números de identificação do estudo
- MCC-13971
- 7032 (Outro identificador: CTEP)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em PS-341
-
Mayo ClinicNational Cancer Institute (NCI)ConcluídoLeucemia | Distúrbios Mieloproliferativos CrônicosEstados Unidos
-
M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.ConcluídoLeucemiaEstados Unidos
-
Jules Bordet InstituteConcluídoCarcinoma de Mama Estágio IVBélgica
-
M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.ConcluídoCancro do ovário | Câncer de Trompa de Falópio | Câncer Peritoneal PrimárioEstados Unidos
-
Rasim GucalpMillennium Pharmaceuticals, Inc.RescindidoCâncer de Pulmão de Células Não PequenasEstados Unidos
-
M.D. Anderson Cancer CenterConcluídoMieloma múltiploEstados Unidos
-
Beijing Chao Yang HospitalInscrevendo-se por conviteMieloma múltiplo | BortezomibeChina
-
Sidney Kimmel Cancer Center at Thomas Jefferson...ConcluídoEstudo sobre a Segurança e Eficácia do VELCADE® no Tratamento da Doença do Enxerto versus HospedeiroDoença do Enxerto contra o HospedeiroEstados Unidos
-
M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.ConcluídoLinfoma de Células BEstados Unidos
-
University of ChicagoNational Cancer Institute (NCI)Concluído