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

NCT00077207 | Completed Results DMC

• 4 other identifiers: ACNS0223CDR0000350005COG-ACNS0223NCI-2012-02572
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Central Nervous System Tumor

Keywords

untreated childhood cerebellar astrocytoma; untreated childhood visual pathway and hypothalamic glioma; childhood spinal cord neoplasm; childhood oligodendroglioma; childhood low-grade cerebral astrocytoma

Outcome Measures

Primary Outcomes (2)

• Short Term Feasibility Success

  Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure.

  24 weeks

• Long Term Feasibility Success

  Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success.

  60 weeks

Secondary Outcomes (5)

• Number of Participants Who Experienced Toxic Death

  Up to 6 years after the start of protocol therapy

• Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.

  Up to 18 months of protocol therapy

• Percent Probability of Progression-free Survival (PFS)

  3 years

• Percentage Probability of Event-free Survival (EFS)

  Six years

• Total Number of Patients Experiencing a Response

  Up to 18 months of protocol therapy

Study Arms (1)

Treatment (carboplatin, vincristine sulfate, temozolomide)

EXPERIMENTAL

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.

Drug: carboplatin; Drug: temozolomide; Drug: vincristine sulfate

Interventions

carboplatin DRUG

Given IV

Also known as: Paraplatin, NSC #241240

Treatment (carboplatin, vincristine sulfate, temozolomide)

temozolomide DRUG

Given orally

Also known as: Temodar, NSC# 362856

Treatment (carboplatin, vincristine sulfate, temozolomide)

vincristine sulfate DRUG

Given IV

Also known as: Oncovin, VCR, LCR, NSC #67574

Treatment (carboplatin, vincristine sulfate, temozolomide)

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Brain Neoplasms; Central Nervous System Neoplasms; Spinal Cord Neoplasms; Oligodendroglioma

Interventions

Carboplatin; Temozolomide; Vincristine

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

Resultsreportingcoordinator@childrensoncologygroup.org

352-273-0558

Study Officials

• Murali M. Chintagumpala, MD

  Texas Children's Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: July 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2013
• Last Updated: May 16, 2018
• Results First Posted: July 2, 2014

Record last verified: 2018-04

Locations

US (1)