Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma

NCT ID: NCT00077207

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2013-12-31

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas.

Secondary

• Determine response rate in patients treated with this regimen.
• Determine 3-year progression-free survival and overall survival of patients treated with this regimen.
• Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen.

OUTLINE: This is a pilot study.

• Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy.
• Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Conditions

Brain Tumor; Central Nervous System Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (carboplatin, vincristine sulfate, temozolomide)

Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given IV

temozolomide

Intervention Type: DRUG

Given orally

vincristine sulfate

Intervention Type: DRUG

Given IV

Interventions

carboplatin

Given IV

Intervention Type: DRUG

temozolomide

Given orally

Intervention Type: DRUG

vincristine sulfate

Given IV

Intervention Type: DRUG

Other Intervention Names

Paraplatin; NSC #241240; Temodar; NSC# 362856; Oncovin; VCR; LCR; NSC #67574

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murali M. Chintagumpala, MD

Role: STUDY_CHAIR

Texas Children's Cancer Center

Locations

Childrens Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

References

Chintagumpala MM, Adesina A, Morriss MC, et al.: A pilot study using carboplatin, vincristine, and temozolomide for children with progressive/symptomatic low-grade glioma: A Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 28 (Suppl 15): A-9539, 2010.

Reference Type: RESULT

Other Identifiers

CDR0000350005

Identifier Type: OTHER

Identifier Source: secondary_id

COG-ACNS0223

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-02572

Identifier Type: OTHER

Identifier Source: secondary_id

ACNS0223

Identifier Type: -

Identifier Source: org_study_id