Low dose chemotherapy versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies

Low dose chemotherapy (Metronomic Therapy) versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies: a double blind placebo controlled randomized study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003734

Enrollment

200

Registered

2013-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Refractory Childhood cancer

Interventions

Intervention1: Low dose chemotherapy: Etoposide(50 mg/m2/d) Thalidomide (at 3mg/kg/d) Celecoxib (100 mg BID for patients 20 kg, 200 mg BID for patients 20â??50 kg, and 400 mg BID for patients 50

Eligibility

Inclusion criteria

Inclusion criteria: 1. Refractory/Progressive non hematopoietic extracranial solid tumors following treatment with atleast 2 lines of chemotherapy. 2. Good performance status (at least ambulatory patient) 3. Age: 5-18 years 4. Recovered from all acute toxic effects of earlier therapy 5. Absolute neutrophil count > 1X 109/L 6. Absolute platelet count > 75 x 109/L 7. Normal renal functions 8. Serum bilirubin

Exclusion criteria

Exclusion criteria: 1. Uncontrolled concurrent illness or active infection 2. Positive serology for human immunodeficiency. 3. Unable to swallow oral medication 4. Pregnant and breast-feeding

Design outcomes

Primary

Measure	Time frame
1.To assess the effect of metronomic chemotherapy on PFS.Timepoint: May 2013 to June 2015	—

Secondary

Measure	Time frame
1. To assess the effect of metronomic chemotherapy on QOL. 2. To assess the effect of metronomic chemotherapy on OS. 3. To correlate the survival with biomarkers of angiogenesis (VEGF levels). Timepoint: May 2013 to June 2015	—

Countries

India

Contacts

Public ContactSameer Bakhshi

Dr. BRA IRCH, AIIMS

sambakh@hotmail.com91-11-26588153

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026