Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
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|ClinicalTrials.gov Identifier: NCT00002463|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : February 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of methotrexate, mechlorethamine, vincristine, procarbazine, and prednisone in treating children with astrocytomas or primitive neuroectodermal tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: MOPP Regimen Drug: Leucovorin Calcium Drug: Mechlorethamine Hydrochloride Drug: Methotrexate Drug: Prednisone Drug: Procarbazine Hydrochloride Drug: Vincristine Sulfate Procedure: Conventional Surgery||Phase 2|
OBJECTIVES: I. Determine the efficacy of high-dose methotrexate (HMTX) in combination with mechlorethamine, vincristine, prednisone, and procarbazine (MOPP) in infants or young children with primitive neuroectodermal tumors (PNET) (including medulloblastoma, anaplastic ependymoma, ependymoblastoma, or pineoblastoma) or high-grade astrocytoma. II. Determine whether the addition of HMTX to MOPP (MMOPP) improves the continuous complete response rate of MOPP alone and eliminates the need for salvage with radiotherapy in these patients. III. Determine the ability of MMOPP to provide neuroaxis prophylaxis or to treat spinal metastasis without radiotherapy in infants or young children with PNET. IV. Determine the toxicity of this regimen in terms of neurologic and neuropsychologic sequelae, growth, and development in these patients. V. Correlate the efficacy of this regimen with the histopathologic diagnosis of these patients. VI. Determine the optimum method for radiographic evaluation of spinal cord disease in patients with PNET. VII. Determine the utility of sequential spinal cord radiography as a means of monitoring PNET in these patients.
OUTLINE: Patients undergo maximum tumor debulking. Patients who have undergone incomplete resection proceed to induction. Patients with a primary diagnosis of primitive neuroectodermal and pineal tumors or glioblastoma multiforme who have undergone total resection proceed to induction. Induction: Patients receive high dose methotrexate (HMTX) IV over 6 hours on day 1. Beginning 3 hours after completion of HMTX infusion, leucovorin calcium (CF) is administered IV over 30 minutes every 3 hours for 9 doses. Beginning 3 hours after completion of the last CF infusion, oral CF is administered every 6 hours for 8 doses. Patients receive a second HMTX infusion beginning 1 week after completion of the first HMTX infusion. Beginning 1 week after completion of the second HMTX infusion, patients receive mechlorethamine IV and vincristine IV on days 1 and 8, oral procarbazine and oral prednisone on days 1-10, and tapered doses of prednisone on days 11-13 (MOPP). Maintenance: Beginning 4 weeks after initiating the first course of MOPP, patients receive HMTX on day 1 and MOPP beginning on day 4. Treatment continues every 31 days in the absence of disease progression or unacceptable toxicity. After 1 year or 14 doses of HMTX, whichever occurs first, HMTX is discontinued and treatment with MOPP alone continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Treatment is discontinued after 2 years if the patient is in continuous complete remission.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study within 24-30 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma|
|Study Start Date :||February 1989|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2008|
Experimental: Combination Chemotherapy
Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine
Drug: MOPP Regimen
Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP)Drug: Leucovorin Calcium Drug: Mechlorethamine Hydrochloride Drug: Methotrexate Drug: Prednisone Drug: Procarbazine Hydrochloride Drug: Vincristine Sulfate Procedure: Conventional Surgery
- Number of Patient with Overall Response [ Time Frame: Every 31 days ]
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): NCT00002463
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Joann Ater, MD||M.D. Anderson Cancer Center|