N/A
Completed N=66
Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
brain tumor · Central Nervous System Tumor
Source: ClinicalTrials.gov NCT00077207 ↗
Enrolled (actual)
66
Serious AEs
9.4%
Results posted
Jul 2014
Primary outcomePrimary: Short Term Feasibility Success — 25 participants
Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Term Feasibility Success |
25 | — |
| PRIMARY Long Term Feasibility Success |
41 | — |
| SECONDARY Number of Participants Who Experienced Toxic Death |
— | — |
| SECONDARY Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. |
43 | — |
| SECONDARY Percent Probability of Progression-free Survival (PFS) |
60.59 | — |
| SECONDARY Percentage Probability of Event-free Survival (EFS) |
40.89 | — |
| SECONDARY Total Number of Patients Experiencing a Response |
2; 15; 36; 7 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following:
- WHO grade I or II astrocytoma
- Grade I or II oligodendrogliomas
- Mixed oligodendrogliomas
- Gangliogliomas
- Measurable disease
- Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed
- Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome
- Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms)
- No diffuse brain stem tumors
- No type 1 neurofibromatosis
PATIENT CHARACTERISTICS:
Age
- 10 and under
Performance status
- ECOG 0-2
- Lansky 50-100%
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 8.0 gm/dL
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT < 2.5 times ULN
Renal
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
- Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunomodulating agents
Chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Prior corticosteroids allowed
- No concurrent corticosteroids except for the treatment of increased intracranial pressure
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- Prior surgery allowed
Other
- No other prior therapy
Data sourced from ClinicalTrials.gov (NCT00077207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.