Clinical trial · Interventional
Low Dose Chemotherapy Versus Best Supportive Care in Progressive 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Childhood Neoplasm | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low dose chemotherapy
- description
- 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
- interventionNames
- Drug: Low dose chemotherapy
- type
- PLACEBO_COMPARATOR
- label
- Best supportive care
- description
- 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
- interventionNames
- Drug: Low dose chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPramanik R, Agarwala S, Sreenivas V, Dhawan D, Bakhshi S. Quality of life in paediatric solid tumours: a randomised study of metronomic chemotherapy versus placebo. BMJ Support Palliat Care. 2023 Jun;13(2):234-237. doi: 10.1136/bmjspcare-2020-002731. Epub 2021 Jan 19. PMID 33468507
- DERIVEDPramanik R, Agarwala S, Gupta YK, Thulkar S, Vishnubhatla S, Batra A, Dhawan D, Bakhshi S. Metronomic Chemotherapy vs Best Supportive Care in Progressive Pediatric Solid Malignant Tumors: A Randomized Clinical Trial. JAMA Oncol. 2017 Sep 1;3(9):1222-1227. doi: 10.1001/jamaoncol.2017.0324. PMID 28384657