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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000350005 | Other Identifier | Clinical Trials.gov | |
| COG-ACNS0223 | Other Identifier | Children's Oncology Group | |
| NCI-2012-02572 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Toxic Death | 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. | Up to 6 years after the start of protocol therapy |
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DISEASE CHARACTERISTICS:
Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following:
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Murali M. Chintagumpala, MD | Texas Children's Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Oncology Group | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25854526 | Result | Chintagumpala M, Eckel SP, Krailo M, Morris M, Adesina A, Packer R, Lau C, Gajjar A. A pilot study using carboplatin, vincristine, and temozolomide in children with progressive/symptomatic low-grade glioma: a Children's Oncology Group studydagger. Neuro Oncol. 2015 Aug;17(8):1132-8. doi: 10.1093/neuonc/nov057. Epub 2015 Apr 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient. | Posted | Number | participants | 24 weeks |
|
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66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 352-273-0558 | Resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D013120 | Spinal Cord Neoplasms |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077204 | Temozolomide |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
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| temozolomide | Drug | Given orally |
|
|
| vincristine sulfate | Drug | Given IV |
|
|
| Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. |
Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy. |
| Up to 18 months of protocol therapy |
| Percent Probability of Progression-free Survival (PFS) | Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment. | 3 years |
| Percentage Probability of Event-free Survival (EFS) | Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment. | Six years |
| Total Number of Patients Experiencing a Response | 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. | Up to 18 months of protocol therapy |
| Withdrawal by Subject |
|
| Ineligible |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient. | Posted | Number | participants | 60 weeks |
|
|
|
| Secondary | Number of Participants Who Experienced Toxic Death | 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. | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Posted | Count of Participants | Participants | Up to 6 years after the start of protocol therapy |
|
|
|
| Secondary | Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia. | Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy. | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Posted | Count of Participants | Participants | Up to 18 months of protocol therapy |
|
|
|
| Secondary | Percent Probability of Progression-free Survival (PFS) | Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment. | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Posted | Number | 95% Confidence Interval | Percent probability PFS | 3 years |
|
|
|
| Secondary | Percentage Probability of Event-free Survival (EFS) | Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment. | Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure. | Posted | Number | 95% Confidence Interval | percent probability EFS | Six years |
|
|
|
| Secondary | Total Number of Patients Experiencing a Response | 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. | Sixty-five (65) eligible patients were enrolled and received protocol therapy. Of these patients, 60 had data submission sufficient to determine response. | Posted | Count of Participants | Participants | Up to 18 months of protocol therapy |
|
|
|
| 6 |
| 64 |
| 50 |
| 64 |
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Eye disorders - Other, specify | Eye disorders |
|
| Neutrophil count decreased | Investigations |
|
| Platelet count decreased | Investigations |
|
| Proteinuria | Renal and urinary disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Acidosis | Metabolism and nutrition disorders |
|
| Agitation | Psychiatric disorders |
|
| Alanine aminotransferase increased | Investigations |
|
| Alkaline phosphatase increased | Investigations |
|
| Allergic reaction | Immune system disorders |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Anaphylaxis | Immune system disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Arthritis | Musculoskeletal and connective tissue disorders |
|
| Aspartate aminotransferase increased | Investigations |
|
| Ataxia | Nervous system disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Blood antidiuretic hormone abnormal | Investigations |
|
| Blood bilirubin increased | Investigations |
|
| Blood corticotrophin decreased | Investigations |
|
| Blurred vision | Eye disorders |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders |
|
| Bruising | Injury, poisoning and procedural complications |
|
| Cardiac disorders - Other, specify | Cardiac disorders |
|
| Catheter related infection | Infections and infestations |
|
| Cholesterol high | Investigations |
|
| Cognitive disturbance | Nervous system disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Creatinine increased | Investigations |
|
| Cushingoid | Endocrine disorders |
|
| Cystitis noninfective | Renal and urinary disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Dermatitis radiation | Injury, poisoning and procedural complications |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry skin | Skin and subcutaneous tissue disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Edema face | General disorders |
|
| Enterocolitis infectious | Infections and infestations |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Esophageal infection | Infections and infestations |
|
| Extraocular muscle paresis | Eye disorders |
|
| Eye disorders - Other, specify | Eye disorders |
|
| Eye infection | Infections and infestations |
|
| Facial pain | General disorders |
|
| Fatigue | General disorders |
|
| Febrile neutropenia | Blood and lymphatic system disorders |
|
| Fever | General disorders |
|
| Flu like symptoms | General disorders |
|
| General disorders and administration site conditions - Other, specify | General disorders |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders |
|
| Gum infection | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| Hydrocephalus | Nervous system disorders |
|
| Hypercalcemia | Metabolism and nutrition disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| Hyperkalemia | Metabolism and nutrition disorders |
|
| Hypermagnesemia | Metabolism and nutrition disorders |
|
| Hypernatremia | Metabolism and nutrition disorders |
|
| Hypertension | Vascular disorders |
|
| Hypoalbuminemia | Metabolism and nutrition disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Hypoglycemia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hypomagnesemia | Metabolism and nutrition disorders |
|
| Hyponatremia | Metabolism and nutrition disorders |
|
| Hypophosphatemia | Metabolism and nutrition disorders |
|
| Hypotension | Vascular disorders |
|
| Ileus | Gastrointestinal disorders |
|
| Infections and infestations - Other, specify | Infections and infestations |
|
| Insomnia | Psychiatric disorders |
|
| Intraoperative neurological injury | Injury, poisoning and procedural complications |
|
| Investigations - Other, specify | Investigations |
|
| Irritability | General disorders |
|
| Left ventricular systolic dysfunction | Cardiac disorders |
|
| Lymphocyte count decreased | Investigations |
|
| Memory impairment | Nervous system disorders |
|
| Middle ear inflammation | Ear and labyrinth disorders |
|
| Mucositis oral | Gastrointestinal disorders |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Neck pain | Musculoskeletal and connective tissue disorders |
|
| Nervous system disorders - Other, specify | Nervous system disorders |
|
| Neutrophil count decreased | Investigations |
|
| Non-cardiac chest pain | General disorders |
|
| Oculomotor nerve disorder | Nervous system disorders |
|
| Optic nerve disorder | Eye disorders |
|
| Oral pain | Gastrointestinal disorders |
|
| Otitis media | Infections and infestations |
|
| Pain | General disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Peripheral motor neuropathy | Nervous system disorders |
|
| Peripheral sensory neuropathy | Nervous system disorders |
|
| Personality change | Psychiatric disorders |
|
| Pharyngitis | Infections and infestations |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Photophobia | Eye disorders |
|
| Platelet count decreased | Investigations |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Purpura | Skin and subcutaneous tissue disorders |
|
| Pyramidal tract syndrome | Nervous system disorders |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders |
|
| Rectal hemorrhage | Gastrointestinal disorders |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders |
|
| Rhinitis infective | Infections and infestations |
|
| Seizure | Nervous system disorders |
|
| Serum sickness | Immune system disorders |
|
| Sinus tachycardia | Cardiac disorders |
|
| Sinusitis | Infections and infestations |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders |
|
| Skin infection | Infections and infestations |
|
| Toothache | Gastrointestinal disorders |
|
| Tremor | Nervous system disorders |
|
| Trigeminal nerve disorder | Nervous system disorders |
|
| Upper respiratory infection | Infections and infestations |
|
| Urinary frequency | Renal and urinary disorders |
|
| Urinary tract pain | Renal and urinary disorders |
|
| Urticaria | Skin and subcutaneous tissue disorders |
|
| Vaginal inflammation | Reproductive system and breast disorders |
|
| Vascular disorders - Other, specify | Vascular disorders |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Watering eyes | Eye disorders |
|
| Weight gain | Investigations |
|
| Weight loss | Investigations |
|
| White blood cell decreased | Investigations |
|
| Wound dehiscence | Injury, poisoning and procedural complications |
|
| Wound infection | Infections and infestations |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| Progressive disease |
|