Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study Of Irinotecan and Bevacizumab With Temozolomide in Children With Recurrent/Refractory Central Nervous System Tumors
Verified date | June 2023 |
Source | Johns Hopkins All Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
Status | Completed |
Enrollment | 26 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 23 Years |
Eligibility | Inclusion Criteria: - Medulloblastomas, high-grade glioma, low-grade glioma, and ependymoma are eligible. Other central nervous system tumors may be considered for treatment at discretion of investigator. Pathology is required unless diffuse intrinsic pontine glioma or optic pathway tumor. - The patient should have failed first line therapy and be considered refractory, relapsed, or recurrent. Exceptions are high grade gliomas including brain stem gliomas. - Age 18 months though age 23 years are eligible for this protocol. - The patient may have received any of the agents, but not in this combination. Patients will not be eligible if they have received the combination of bevacizumab and IV irinotecan as prior therapy. They will not be eligible if they had progressive disease on any of these agents. Investigator discretion may also be used. - Bone marrow should be recovered from prior therapy with ANC >1500 and platelets >100,000. - Serum creatinine should be less than institutional upper limit of norm. - ALT/AST <3 times normal and bilirubin <1.5 times normal. - Neurologic symptoms should be stable for 1 week with stable or decreasing doses of steroids. - Patients should not be pregnant or breast feeding. Exclusion Criteria: - Patients with bleeding disorders or on anticoagulants. - Uncontrolled hypertension. - Other risks of bleeding determined on individual basis. - Patients receiving enzyme inducing anticonvulsants. - Patients with significant cardiac or pulmonary dysfunction that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results. - For patients receiving bevacizumab, those who have had surgical procedures should not receive bevacizumab within 28 days of a major procedure, 14 days of an intermediate procedure and 7 days of a minor procedure. Lumbar punctures or placement of PICC lines are not considered minor procedures and may occur at any time prior to or during therapy. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins All Children's Hospital | Brain Tumor Alliance, The V Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of Number of Adverse Events | Collect and grade the all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant. | Two 28-day cycles | |
Secondary | Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents. | Best response by MRIs per definitions in the protocol (complete response, partial response, stable disease, progressive disease). MRI's were obtained every 2 cycles and the best response was reported. | Every 2 cycles up to 24 cycles | |
Secondary | 2 Year Event Free Survival With Children Treated With This Regimen. | 2 year actual event free survival.with children treated with this protocol | 2 year | |
Secondary | To Provide Safety and Efficacy Data for to Recommend Further Larger Studies. | Number participants with grade 3 and 4 hematologic and non-hematologic toxicities. All toxicities are for end of cycle 2. | Two 28 day cycles |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00003935 -
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
|
Phase 1 | |
Terminated |
NCT00107471 -
Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
|
Phase 1/Phase 2 | |
Completed |
NCT00003573 -
Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
|
Phase 2 | |
Recruiting |
NCT05235074 -
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors
|
Phase 1/Phase 2 | |
Suspended |
NCT05308407 -
POWER UP: Participating Online While Exercising to Recover Using Play
|
N/A | |
Terminated |
NCT00477503 -
Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
|
Phase 1 | |
Active, not recruiting |
NCT01985451 -
Pemetrexed and Temozolomide in Treating Patients With Relapsed Primary Central Nervous System Lymphoma (PCNSL)
|
Phase 2 | |
Withdrawn |
NCT00109798 -
Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
|
N/A | |
Completed |
NCT00003141 -
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
|
Phase 1 | |
Completed |
NCT00003203 -
Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors
|
Phase 2 | |
Completed |
NCT02462629 -
Study of BLZ-100 in Pediatric Subjects With CNS Tumors
|
Phase 1 | |
Active, not recruiting |
NCT01735747 -
Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma
|
Phase 2 | |
Recruiting |
NCT00607984 -
Administration of High Dose Thiotepa and Melphalan With Autologous Hematopoietic Stem Cell Transplant in Children and Adolescents With Solid Tumors
|
N/A | |
Completed |
NCT00899834 -
DNA Analysis of Tumor Tissue Samples From Patients With Diffuse Brain Stem Glioma
|
N/A | |
Completed |
NCT00066248 -
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
|
Phase 2 | |
Completed |
NCT00187226 -
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
|
Phase 2 | |
Completed |
NCT02793466 -
Durvalumab in Pediatric and Adolescent Patients
|
Phase 1 | |
Withdrawn |
NCT01052363 -
OXC401-PO1s/WVU 1309 - A Pilot Study of Fosbretabulin With Bevacizumab in Recurrent High-Grade Gliomas
|
Phase 1 | |
Completed |
NCT00047320 -
Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
|
Phase 2 | |
Completed |
NCT00945828 -
Assessing the Effectiveness of Individual Education Plans for Childhood Cancer Survivors
|
N/A |