Overview

Low Dose Chemotherapy Versus Best Supportive Care in Progressive Pediatric Malignancies

Status:
Completed

Trial end date:
2017-01-01

Target enrollment:
0

Participant gender:
All

Summary

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. HYPOTHESIS The investigators hypothesize that metronomic chemotherapy in progressive pediatric malignancy will improve PFS and QOL. If validated, then this form for therapy will be an option for both the patients and the clinicians, who are left with just an option of best supportive care in such situations of progressive pediatric cancers despite multiple lines of chemotherapy.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

All India Institute of Medical Sciences, New Delhi

Treatments:

Celecoxib
Cyclophosphamide
Etoposide
Etoposide phosphate
Thalidomide

Criteria

Inclusion Criteria:

1. Refractory/Progressive non hematopoietic extracranial solid tumors following treatment
with at least 2 lines of chemotherapy.

2. ECOG performance status (<=3)(at least patients ambulating with crutches or on wheel
chair)

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 <1.5 times the upper limit of normal, and the serum aspartate
aminotransferase and alanine aminotransferase < 5 times the upper limit of normal.

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