Recruitment

Recruitment Status
Completed
Estimated Enrollment
200

Inclusion Criterias

Normal renal functions
Recovered from all acute toxic effects of earlier therapy
Absolute platelet count > 75 x 109/L
...
Normal renal functions
Recovered from all acute toxic effects of earlier therapy
Absolute platelet count > 75 x 109/L
Age: 5-18 years
ECOG performance status (<=3)(at least patients ambulating with crutches or on wheel chair)
Serum bilirubin <1.5 times the upper limit of normal, and the serum aspartate aminotransferase and alanine aminotransferase < 5 times the upper limit of normal.
Absolute neutrophil count > 1X 109/L
Refractory/Progressive non hematopoietic extracranial solid tumors following treatment with at least 2 lines of chemotherapy.

Exclusion Criterias

Positive serology for human immunodeficiency.
Unable to swallow oral medication
Pregnant and breast-feeding
...
Positive serology for human immunodeficiency.
Unable to swallow oral medication
Pregnant and breast-feeding
Uncontrolled concurrent illness or active infection

Summary

Conditions
Malignant Childhood Neoplasm
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 18 years
Gender
Both males and females

Description

Many of the pediatric malignancies are not curable on progression on front line or 2nd line chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases the QOL. The usual therapy offered to such patients is best supportive care. Metronomic chemotherapy can induce tu...

Many of the pediatric malignancies are not curable on progression on front line or 2nd line chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases the QOL. The usual therapy offered to such patients is best supportive care. Metronomic chemotherapy can induce tumor stabilization or tumor responses in patients with cancer that are refractory or have relapsed after conventional chemotherapy. Whether metronomic therapy is better than best supportive care is not known. In order to do so, a study is required which may compare metronomic therapy with a placebo therapy on PFS and QOL in relapsed refractory cases of pediatric solid tumors who have failed at least two lines of chemotherapy. It will be double blind randomized study. One group will receive metronomic therapy along with best supportive care and other will receive placebo and best supportive care. The treatment will be continued till progression is documented. Metronomic chemotherapy schedule : Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size. Cycle A Daily oral Thalidomide (at 3mg/kg) Daily oral Celecoxib (100 mg BID for patients < 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients > 50 kg) Daily oral Etoposide (50 mg/m2/d) Cycle B Daily oral Thalidomide (at 3mg/kg) Daily oral Celecoxib (100 mg BID for patients < 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients > 50 kg) Daily oral Cyclophosphamide (2.5 mg/kg/d to a maximum of 100 mg/d) every 21 days Placebo: Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) Capsules of same size and color as used in metronomic therapy Best supportive care Management of pain as per WHO standard for pain management The dose of medications in capsules have to be rounded off to the nearest capsule size. Instead of rounding off on the daily dose, the total dose over the week would be calculated and rounded off and divided over 5-6 days in a week. This is being done so as to prevent any extra dosing. If any grade 3-4 toxicity occurs in the first course, then the dose for chemotherapy would be reduced in the subsequent course by 20%.

Inclusion Criterias

Normal renal functions
Recovered from all acute toxic effects of earlier therapy
Absolute platelet count > 75 x 109/L
...
Normal renal functions
Recovered from all acute toxic effects of earlier therapy
Absolute platelet count > 75 x 109/L
Age: 5-18 years
ECOG performance status (<=3)(at least patients ambulating with crutches or on wheel chair)
Serum bilirubin <1.5 times the upper limit of normal, and the serum aspartate aminotransferase and alanine aminotransferase < 5 times the upper limit of normal.
Absolute neutrophil count > 1X 109/L
Refractory/Progressive non hematopoietic extracranial solid tumors following treatment with at least 2 lines of chemotherapy.

Exclusion Criterias

Positive serology for human immunodeficiency.
Unable to swallow oral medication
Pregnant and breast-feeding
...
Positive serology for human immunodeficiency.
Unable to swallow oral medication
Pregnant and breast-feeding
Uncontrolled concurrent illness or active infection

Locations

New Delhi, Delhi, 110029
New Delhi, Delhi, 110029

Tracking Information

NCT #
NCT01858571
Collaborators
Not Provided
Investigators
  • Principal Investigator: Sameer Bakhshi, MD All India Institute of Medical Sciences, New Delhi
  • Sameer Bakhshi, MD All India Institute of Medical Sciences, New Delhi