Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Surgery | Procedure | — | UNRESOLVED |
| Leucovorin Calcium | Drug | Leucovorin | ALIAS |
| Mechlorethamine Hydrochloride | Drug | Mechlorethamine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| MOPP Regimen | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Procarbazine Hydrochloride | Drug | Procarbazine | ALIAS |
| Vincristine Sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Chemotherapy
- description
- Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine
- interventionNames
- Drug: MOPP Regimen
- Drug: Leucovorin Calcium
- Drug: Mechlorethamine Hydrochloride
- Drug: Methotrexate
- Drug: Prednisone
- Drug: Procarbazine Hydrochloride
- Drug: Vincristine Sulfate
- Procedure: Conventional Surgery
Primary outcomes (1)
- measure
- Number of Patient with Overall Response
- timeFrame
- Every 31 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 3 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven previously untreated (except surgically) primitive neuroectodermal tumors (including medulloblastoma, anaplastic ependymoma, ependymoblastoma, or pineoblastoma) or high-grade astrocytomas Low-grade astrocytomas or optic tract tumors that are incompletely resected and have a progressive course not amenable to further surgery may also be allowed Evaluable disease by MRI, CT scan, or CT myelography PATIENT CHARACTERISTICS: Age: Under 4 years Performance status: Not specified Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 90 IU/dL Renal: Creatinine clearance greater than 80 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) No prior high-dose methotrexate No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: Recovered from acute toxic effects of any prior therapy Must be on a tyramine-free diet during procarbazine administration
References
Publications (2)
- RESULTAter J, Worth L, Bruner J, et al.: Young children treated with MOPP or methotrexate-MOP for medulloblastoma: identification of a subset of patients with good prognosis. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1397, 1995.
- RESULTAter JL, van Eys J, Yung WK, et al.: Response to methotrexate, mechlorethamine, vincristine, procarbazine, and prednizone (MMOPP) for brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 10: A-370, 125, 1991.