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Low Dose Chemotherapy (Metronomic Therapy) Versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies: a Double Blind Placebo Controlled Randomized Study


Phase 3
5 Years
18 Years
Not Enrolling
Both
Malignant Childhood Neoplasm

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Trial Information

Low Dose Chemotherapy (Metronomic Therapy) Versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies: a Double Blind Placebo Controlled Randomized Study


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 atleast 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


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 <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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

Sameer Bakhshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Drugs Controller General of India

Study ID:

IEC/NP-63/2013

NCT ID:

NCT01858571

Start Date:

May 2013

Completion Date:

June 2015

Related Keywords:

  • Malignant Childhood Neoplasm
  • Childhood Cancer
  • Neoplasms

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