Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: CCNU and bevacizumab: CCNU would be administered in a dose of 110 mg/m2 once on day 1 of 42 days cycle. It would be administered with concurrent 5HT3 inhibitor. The dose would be round
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Participants must have recurrent glioblastoma or high grade glioma a. The diagnosis of recurrent glioblastoma or high grade glioma could be based on any of the below mentioned features i. Histopathological confirmation of recurrence ii. Clinico-radiological features: Unequivocal clinical or radiological features suggesting recurrence or progression 2. Age : Any age above 18 years. No maximum age. 3. ECOG performance status 4. Participants must have normal organ and marrow function as defined below: a. Leukocytes >=2,000/mcL or ANC >= 1500/mcL b. Platelets >=100,000/mcL c. Total bilirubin d. AST(SGOT)/ALT(SGPT) e. Calculated Creatinine clearance > 30 ml/min 5. The effects of CCNU on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol. 6. Both men and women of all races and ethnic groups are eligible for this trial. 7. Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. ability to undergo video follow up) 8. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Participants who are receiving any other investigational agents. 2. Within 3 weeks of administration of chemotherapeutic agent 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 4. Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. 5. Pregnant women and breastfeeding women are excluded from this study because CCNU has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study. 6. Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis 7. Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results 8. Contraindication for receiving bevacizumab ( presence of any one factor excludes use of bevacizumab) i. a history of hypersensitivity reaction to bevacizumab or other recombinant human or humanized antibodies, or Chinese hamster ovary cell products ii. 28 days before or after major surgery and until the surgical wound is fully healed iii. uncontrolled hypertension iv. congenital bleeding diathesis, acquired coagulopathy, full dose anticoagulation v. history of arterial thromboembolic events within the last 6 months vi. Presence of active hemoptysis (more than 1 tablespoon per day) vii. Presence of peptic ulcer disease or rectal fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To estimate the overall survival.Timepoint: OS will be defined in time in months between the date of enrollment to date of death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To estimate the progression of free survivalTimepoint: PFS will be defined time in months between the date of enrollment to date of progression or death whichever is earlier.;2. To estimate the time to deterioration in QOL.Timepoint: After completion of treatment;3. To estimate the QTWiST (quality of life without symptoms or toxicity).Timepoint: Till progression;4. To estimate the rate of grade 3-5 adverse eventsTimepoint: After completion of treatment | — |
Countries
India
Contacts
Public ContactDr Vijay M Patil
TATA MEMORIAL HOSPITAL
Outcome results
None listed