Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
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| ClinicalTrials.gov Identifier: NCT00077207 |
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Recruitment Status :
Completed
First Posted : February 11, 2004
Results First Posted : July 2, 2014
Last Update Posted : May 16, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Tumor Central Nervous System Tumor | Drug: carboplatin Drug: temozolomide Drug: vincristine sulfate | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 66 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: carboplatin
Given IV
Other Names:
Drug: temozolomide Given orally
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
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- Short Term Feasibility Success [ Time Frame: 24 weeks ]
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.
- Long Term Feasibility Success [ Time Frame: 60 weeks ]
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.
- Number of Participants Who Experienced Toxic Death [ Time Frame: Up to 6 years after the start of protocol therapy ]Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.
- Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. [ Time Frame: Up to 18 months of protocol therapy ]Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.
- Percent Probability of Progression-free Survival (PFS) [ Time Frame: 3 years ]Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.
- Percentage Probability of Event-free Survival (EFS) [ Time Frame: Six years ]Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.
- Total Number of Patients Experiencing a Response [ Time Frame: Up to 18 months of protocol therapy ]Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077207
| United States, Pennsylvania | |
| Childrens Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Chair: | Murali M. Chintagumpala, MD | Texas Children's Cancer Center |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00077207 |
| Other Study ID Numbers: |
ACNS0223 CDR0000350005 ( Other Identifier: Clinical Trials.gov ) COG-ACNS0223 ( Other Identifier: Children's Oncology Group ) NCI-2012-02572 ( Other Identifier: NCI ) |
| First Posted: | February 11, 2004 Key Record Dates |
| Results First Posted: | July 2, 2014 |
| Last Update Posted: | May 16, 2018 |
| Last Verified: | April 2018 |
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untreated childhood cerebellar astrocytoma untreated childhood visual pathway and hypothalamic glioma childhood spinal cord neoplasm childhood oligodendroglioma childhood low-grade cerebral astrocytoma |
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Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Carboplatin Vincristine Temozolomide Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |