Early Access Program voor niet-spierinvasieve high grade blaaskanker
Er is een early access program opgestart (fase2 trials) naar de behandeling van niet spierinvasieve blaaskanker bij patiënten waarbij BCG niet, of niet meer werkt en waarvoor blaasverwijdering niet tot de mogelijkheden behoort. Het betreft behandelingen op basis van het adenovirus (verkoudheidsvirus). De link naar de info: http://mytomorrows.com/program/safety-and-efficacy-of-cg0070-oncolytic-virus-regimen-in-patients-wit... en de tekst:
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder CancerDecember 4, 2014
Brief summary:This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis andCis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol(NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.
Official title:Phase II Safety and Efficacy Study of CG0070 Oncolytic Vector Regimen in Patients With High Grade Non-Muscle Invasive Bladder Carcinoma Disease (NMIBC) Who Have Failed BCG and Refused Cystectomy
Eligibility:Inclusion Criteria:- • Patients must have pathologically confirmed high grade disease (HG), as defined bythe 2004 WHO classification system- Patients must have no evidence of muscle invasive disease- Patient must fall under one of the following criteria:1. Patients who were first enrolled in the BOND protocol but have failed toachieve a complete response or have relapsed following a complete responseat 3 months after receiving control treatments2. OR patients who were first enrolled in the BOND protocol but have relapsedfollowing a complete response lasting over a year after receiving CG0070treatments3. OR patients who have Ta/T1 high grade, refused cystectomy and are CG0070naïve4. OR patients from the exBOND protocol who experienced a tumor relapse withno disease progression after sustaining 12 months or longer completeresponse duration- For Cis patients or Cis with Ta and/or T1 only:1. Tumor must be considered unresectable or with residual disease.2. Patients must be declared as medically unfit for cystectomy.3. No disease progression from disease status at the beginning of the BONDtrial.- For Ta/T1 HG Patients:1. They must have also received at least one prior course of BCG therapy perthe recommended schedules. Patients can have either failed BCG inductiontherapy within a six-month period or have been successfully treated withBCG, but subsequently found to have recurrence. The standard course ofintravesical BCG therapy must include at least six weekly treatments(allowable range of instillations per course is 4-9) within a six-monthperiod2. They must have received 2 or more intravesical chemotherapy regimens otherthan BCG3. They must have relapsed within 6 months of their last treatment- 18 years of age or older- Radical cystectomy has been declined by the patient in a signed special sectionof the informed consent, whereby there is a clear explanation by theinvestigator to the subject that a delay of cystectomy may increase his/herchance of disease progression, the results of which may lead to serious and lifethreatening consequences.- Patients must be able to enter into the study within five weeks of their mostrecent diagnostic procedure, which is usually a diagnostic biopsy, atransurethral resection of bladder tumor (TURBT) procedure or other diagnosticscanning such as CT and PET procedures.- Histopathologically confirmed, transitional cell (urothelial) carcinoma.Urothelial tumors with mixed histology (but with <50% variant) are eligible.- Eastern Cooperative Oncology Group (ECOG) performance status <2.- Not pregnant or lactating- Patients with child bearing potential must agree to use adequate contraception- Agree to study specific informed consent and HIPAA authorization for release ofpersonal health information- Adequate baseline CBC, renal and hepatic function. Parameters described as.WBC>3000 cells/mm3, ANC>1,000 cells/mm3, hemoglobin>10g/dL, and platelet count>100,000 cells/mm3- Adequate renal function: serum creatinine <2.0mg/dL- Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal- PT/INR, PTT, and fibrinogen within institutional normal limits- Absolute lymphocyte count ≥ 800/μL before the first dose of CG0070Exclusion Criteria:- Previous systemic chemotherapy or radiation for bladder cancer. Note: Priorimmunotherapy or intravesical (administered within the bladder) chemotherapy forsuperficial disease is acceptable- History of anaphylactic reaction following exposure to humanized or humantherapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derivedproducts, clinically meaningful allergic reactions or any known hypersensitivityor prior reaction to any of the formulation excipients in the study drugs.- Known infection with HIV, HBV or HCV.- Anticipated use of chemotherapy, radiotherapy, or other immunotherapy notspecified in the study protocol while on study- Any underlying medical condition that, in the Investigator's opinion, will makethe administration of study vector hazardous to the patient, would obscure theinterpretation of adverse events, or not permit adequate surgical resection.- Systemic treatment on any investigational clinical trial within 28 days prior toregistration.- Concurrent treatment with immunosuppressive or immunomodulatory agents,including any systemic steroid (exception: inhaled or topically appliedsteroids, and acute and chronic standard dose NSAIDs, are permitted). Use of ashort course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent areaction to the IV contrast used for CT scans.- Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, ortacrolimus within 3 months of study entry.- History of prior experimental cancer vaccine treatment (e.g., dendritic celltherapy, heat shock vaccine)- History of stage III or greater cancer, excluding urothelial cancer. Basal orsquamous cell skin cancers must have been adequately treated and the subjectmust be disease-free at the time of registration. Subjects with a history ofstage I or II cancer, must have been adequately treated and have beendisease-free for ≥ 3 years at the time of registration.- Progressive viral or bacterial infectiono All infections must be resolved and the patient must remain afebrile for sevendays without antibiotics prior to being placed on study- Unwilling or unable to comply with the protocol or cooperate fully with theinvestigator and site personnel- Evidence of disease progression compared to disease status before BOND protocolfor NMIBCis patients.- Patient have relapsed less than 1 year after or who are refractory to treatmentwith CG0070.- Cis, and Cis with Ta and/or T1 patients who are medically fit for cystectomy.Both18 YearsN/A
Contacts:Alex Yeung, MBBS9492007680alex.yeung@coldgenesys.net
Source: ClinicalTrials.gov processed this data on December 02, 2014
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder CancerDecember 4, 2014
Brief summary:This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis andCis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol(NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.
Official title:Phase II Safety and Efficacy Study of CG0070 Oncolytic Vector Regimen in Patients With High Grade Non-Muscle Invasive Bladder Carcinoma Disease (NMIBC) Who Have Failed BCG and Refused Cystectomy
Eligibility:Inclusion Criteria:- • Patients must have pathologically confirmed high grade disease (HG), as defined bythe 2004 WHO classification system- Patients must have no evidence of muscle invasive disease- Patient must fall under one of the following criteria:1. Patients who were first enrolled in the BOND protocol but have failed toachieve a complete response or have relapsed following a complete responseat 3 months after receiving control treatments2. OR patients who were first enrolled in the BOND protocol but have relapsedfollowing a complete response lasting over a year after receiving CG0070treatments3. OR patients who have Ta/T1 high grade, refused cystectomy and are CG0070naïve4. OR patients from the exBOND protocol who experienced a tumor relapse withno disease progression after sustaining 12 months or longer completeresponse duration- For Cis patients or Cis with Ta and/or T1 only:1. Tumor must be considered unresectable or with residual disease.2. Patients must be declared as medically unfit for cystectomy.3. No disease progression from disease status at the beginning of the BONDtrial.- For Ta/T1 HG Patients:1. They must have also received at least one prior course of BCG therapy perthe recommended schedules. Patients can have either failed BCG inductiontherapy within a six-month period or have been successfully treated withBCG, but subsequently found to have recurrence. The standard course ofintravesical BCG therapy must include at least six weekly treatments(allowable range of instillations per course is 4-9) within a six-monthperiod2. They must have received 2 or more intravesical chemotherapy regimens otherthan BCG3. They must have relapsed within 6 months of their last treatment- 18 years of age or older- Radical cystectomy has been declined by the patient in a signed special sectionof the informed consent, whereby there is a clear explanation by theinvestigator to the subject that a delay of cystectomy may increase his/herchance of disease progression, the results of which may lead to serious and lifethreatening consequences.- Patients must be able to enter into the study within five weeks of their mostrecent diagnostic procedure, which is usually a diagnostic biopsy, atransurethral resection of bladder tumor (TURBT) procedure or other diagnosticscanning such as CT and PET procedures.- Histopathologically confirmed, transitional cell (urothelial) carcinoma.Urothelial tumors with mixed histology (but with <50% variant) are eligible.- Eastern Cooperative Oncology Group (ECOG) performance status <2.- Not pregnant or lactating- Patients with child bearing potential must agree to use adequate contraception- Agree to study specific informed consent and HIPAA authorization for release ofpersonal health information- Adequate baseline CBC, renal and hepatic function. Parameters described as.WBC>3000 cells/mm3, ANC>1,000 cells/mm3, hemoglobin>10g/dL, and platelet count>100,000 cells/mm3- Adequate renal function: serum creatinine <2.0mg/dL- Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal- PT/INR, PTT, and fibrinogen within institutional normal limits- Absolute lymphocyte count ≥ 800/μL before the first dose of CG0070Exclusion Criteria:- Previous systemic chemotherapy or radiation for bladder cancer. Note: Priorimmunotherapy or intravesical (administered within the bladder) chemotherapy forsuperficial disease is acceptable- History of anaphylactic reaction following exposure to humanized or humantherapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derivedproducts, clinically meaningful allergic reactions or any known hypersensitivityor prior reaction to any of the formulation excipients in the study drugs.- Known infection with HIV, HBV or HCV.- Anticipated use of chemotherapy, radiotherapy, or other immunotherapy notspecified in the study protocol while on study- Any underlying medical condition that, in the Investigator's opinion, will makethe administration of study vector hazardous to the patient, would obscure theinterpretation of adverse events, or not permit adequate surgical resection.- Systemic treatment on any investigational clinical trial within 28 days prior toregistration.- Concurrent treatment with immunosuppressive or immunomodulatory agents,including any systemic steroid (exception: inhaled or topically appliedsteroids, and acute and chronic standard dose NSAIDs, are permitted). Use of ashort course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent areaction to the IV contrast used for CT scans.- Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, ortacrolimus within 3 months of study entry.- History of prior experimental cancer vaccine treatment (e.g., dendritic celltherapy, heat shock vaccine)- History of stage III or greater cancer, excluding urothelial cancer. Basal orsquamous cell skin cancers must have been adequately treated and the subjectmust be disease-free at the time of registration. Subjects with a history ofstage I or II cancer, must have been adequately treated and have beendisease-free for ≥ 3 years at the time of registration.- Progressive viral or bacterial infectiono All infections must be resolved and the patient must remain afebrile for sevendays without antibiotics prior to being placed on study- Unwilling or unable to comply with the protocol or cooperate fully with theinvestigator and site personnel- Evidence of disease progression compared to disease status before BOND protocolfor NMIBCis patients.- Patient have relapsed less than 1 year after or who are refractory to treatmentwith CG0070.- Cis, and Cis with Ta and/or T1 patients who are medically fit for cystectomy.Both18 YearsN/A
Contacts:Alex Yeung, MBBS9492007680alex.yeung@coldgenesys.net
Source: ClinicalTrials.gov processed this data on December 02, 2014
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