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Alkylating agents

Carboplatin alone for Low Grade Glioma

Phase 3
Waitlist Available
Led By Natasha Pillay Smiley, DO
Research Sponsored by Natasha Pillay Smiley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This study is trying to learn and understand if the chemotherapy drug called carboplatin works as well as the standard therapy. The standard therapy for Low Grade Glioma (LGG) in children and young adults is using a combination of carboplatin and vincristine. Studies in children have shown that the use of carboplatin alone has promise of being just as effective for treating LGG as standard therapy. Additionally, this study will try to understand if treatment with carboplatin alone is associated with an improved quality of life for LGG patients and their families.

Eligible Conditions
  • Low Grade Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100
60%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
CONSTIPATION
35%
DIARRHOEA
35%
HYPERTENSION
30%
NEUTROPENIA
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
28%
PERIPHERAL SENSORY NEUROPATHY
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
VOMITING
23%
HEADACHE
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PLATELET COUNT DECREASED
21%
PROTEINURIA
21%
EPISTAXIS
21%
THROMBOCYTOPENIA
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
PYREXIA
16%
COUGH
15%
STOMATITIS
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
HYPOMAGNESAEMIA
14%
BACK PAIN
14%
INSOMNIA
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
ASTHENIA
12%
INFUSION RELATED REACTION
12%
DIZZINESS
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
FEBRILE NEUTROPENIA
8%
ABDOMINAL PAIN UPPER
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
MUCOSAL INFLAMMATION
7%
LYMPHOCYTE COUNT DECREASED
7%
HYPONATRAEMIA
7%
BONE PAIN
7%
MUSCULAR WEAKNESS
7%
PARAESTHESIA
7%
DYSPHONIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
OEDEMA PERIPHERAL
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
DRY MOUTH
5%
MALAISE
5%
DEPRESSION
5%
NASAL CONGESTION
5%
PAIN
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
NECK PAIN
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
ILEUS
2%
PNEUMONIA
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
INTESTINAL OBSTRUCTION
1%
LIVER INJURY
1%
PERITONITIS
1%
UROSEPSIS
1%
DEHYDRATION
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Carboplatin aloneExperimental Treatment1 Intervention
Carboplatin is given once every four weeks, Each 4-week period is considered a cycle. Regimen B will last for 13 cycles which is equivalent to one year (52 weeks). Carboplatin 560 mg/m2 (or 19 mg/kg for children weighing less than 12 kg) IV over 1 hour every 4 weeks
Group II: Carboplatine and VincristineActive Control2 Interventions
Induction: 10 weeks of Carboplatin and Vincristine therapy. Carboplatin 175 mg/m2 give an an IV infusion weeks 1, 2, 3, 4, 7, 8, 9, 10. Vincristine 1.5mg/m2 (0.05 mg/kg if child less than 12 kg) (maximum dose 2.0 mg) give as an IV bolus infusion on weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. Maintenance: Maintenance consists of 8, 6-week cycles of chemotherapy. It begins week 12 of Induction or when peripheral counts recover with ANC \>1,000/µL and platelet count \>100,000/µL. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles. Carboplatin 175 mg/m2 as an IV continuous infusion over 60 minutes on Week 1, 2, 3, 4 of each cycle. Vincristine 1.5 mg/m2 (0.05 mg/ kg for children \<12 kg) (maximum dose 2.0 mg) IV bolus infusion on Week 1, 2, 3 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved

Find a Location

Who is running the clinical trial?

Natasha Pillay SmileyLead Sponsor
Natasha Pillay Smiley, DOPrincipal InvestigatorAttending
~15 spots leftby Sep 2025
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