Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
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| ClinicalTrials.gov Identifier: NCT00003141 |
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Recruitment Status :
Completed
First Posted : November 6, 2003
Last Update Posted : March 28, 2014
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Tumors Central Nervous System Tumors Neuroblastoma Sarcoma | Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation | Phase 1 |
OBJECTIVES:
- Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy.
- Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell (PBSC) rescue in these patients.
- Assess the feasibility of harvesting PBSCs in these patients.
- Determine the complete response rate and overall event-free survival rate in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
Patients undergo surgery for diagnosis and maximal tumor resection.
Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 94 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors |
| Study Start Date : | March 1998 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | October 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (combination chemotherapy, PBSC transplant)
Pts undergo conventional surgery for diagnosis & max tumor resection. In 6 wks of surgery or when stable pts begin induction chemotherapy(cisplatin IV over 6 hrs on day 0; vincristine sulfate IV on days 0,7,14; cyclophosphamide IV over 1 hr on days 1-2; and etoposide IV over 1 hr on days 0-2. 24 hrs after the last cyclophosphamide dose, pts receive filgrastim (G-CSF) & undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 crs. Within 6 wks after induction, pts receive consolidation (carboplatin IV over 2 hrs on days 0-1 next esc. doses of thiotepa IV over 2 hrs. Pts undergo peripheral blood stem cell transplantation 48 hrs after last thiotepa dose. Pts receive G-CSF SC daily on days 3-21. Treatment repeats every 21 days for up to 3 crs. Pts with dose-limiting toxicity due to thiotepa are removed from study. Pts are followed at 4 wks, 3 mths for 1 yr, 6 mths for 3 yrs, annually for 3 yrs or until relapse.
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Biological: filgrastim
Given IV
Other Names:
Drug: carboplatin Given IV
Other Names:
Drug: cisplatin Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: etoposide Given IV
Other Names:
Drug: thiotepa Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation |
- Feasibility [ Time Frame: Up to 4 weeks after completion of study treatment ]Demonstrate the feasibility of administering this regimen, to select an acceptable Thiotepa dose for Consolidation therapy, and to document significant toxicities and estimate their overall rates
- Maximal tolerated dose of thiotepa for consolidation therapy [ Time Frame: 9 weeks ]The dose level will be assigned within 3 working days prior to beginning Consolidation.
- Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV) [ Time Frame: Up to 6 years ]Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Graded using the CCG Toxicity and Complications Criteria.
- Event Free Survival [ Time Frame: From the time of study entry to the first occurrence of death by any cause, progression or recurrence of disease or occurrence of a second malignant neoplasm, assessed up ]
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| Ages Eligible for Study: | up to 2 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically proven malignant brain or spinal cord tumor, including the following:
- Primitive neuroectodermal tumor
- Ganglioneuroblastoma
- Medulloblastoma neuroblastoma
- Desmoplastic medulloblastoma
- Medulloepithelioma
- Ependymoma neuroepithelioma
- Anaplastic ependymoma germ cell tumor
- Astrocytoma germinoma
- Anaplastic astrocytoma
- Embryonal carcinoma
- Glioblastoma endodermal sinus tumor
- Gliosarcoma malignant teratoma
- Choroid plexus carcinoma
- Mixed germ cell tumor
- Cerebellar sarcoma
- Pineoblastoma
- Atypical teratoid/rhabdoid tumor
- Choriocarcinoma
- Teratoma (malignant or with malignant transformations)
- Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 6 months to less than 3 years
Performance Status:
- Not specified
Life Expectancy:
- More than 8 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
Renal:
- Glomerular filtration rate or creatinine clearance greater than 70 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior corticosteroids allowed
Radiotherapy:
- No prior radiotherapy
Surgery:
- No more than 6 weeks since prior surgery
- Recovered from prior surgery (stable)
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): NCT00003141
Show 71 study locations
| Study Chair: | Bruce H. Cohen, MD | The Cleveland Clinic |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003141 |
| Other Study ID Numbers: |
99703 COG-99703 ( Other Identifier: Children's Oncology Group ) CCG-99703 ( Other Identifier: Children's Cancer Group ) CDR0000065924 ( Other Identifier: Clinical Trials.gov ) |
| First Posted: | November 6, 2003 Key Record Dates |
| Last Update Posted: | March 28, 2014 |
| Last Verified: | March 2014 |
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childhood infratentorial ependymoma childhood supratentorial ependymoma disseminated neuroblastoma stage 4S neuroblastoma embryonal childhood rhabdomyosarcoma childhood high-grade cerebral astrocytoma childhood choroid plexus tumor previously untreated childhood rhabdomyosarcoma untreated childhood brain stem glioma untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood cerebellar astrocytoma untreated childhood medulloblastoma newly diagnosed childhood ependymoma |
localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma childhood spinal cord neoplasm childhood atypical teratoid/rhabdoid tumor childhood low-grade cerebral astrocytoma childhood central nervous system choriocarcinoma childhood central nervous system embryonal tumor childhood central nervous system germinoma childhood central nervous system mixed germ cell tumor childhood central nervous system teratoma childhood central nervous system yolk sac tumor |
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Neoplasms Brain Neoplasms Neuroblastoma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cyclophosphamide Thiotepa Cisplatin Carboplatin Etoposide Vincristine Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |