Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00003309 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : January 27, 2010
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy | Phase 2 |
OBJECTIVES:
- Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy.
- Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation.
- Determine the toxic effects associated with this treatment in these patients.
OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 33 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma |
| Study Start Date : | July 1998 |
| Actual Primary Completion Date : | March 2004 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed central nervous system cancer including:
- Medulloblastoma with either local residual disease of greater than 1 cm^2 on MRI following resection or evidence of metastases (M1-4)
- Other primitive neuroectodermal tumors
- Ependymoma with evidence of subarachnoid metastases
- Must have less than 1 cm of midline shift or no acute elevated intercranial pressure
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 125,000/mm^3
- Hemoglobin greater than 10 g/dL
- No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Renal:
- Creatinine greater than 70 mL/min
- No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Pulmonary:
- No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted
- No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Other:
- No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No increasing doses of steroids for intracranial disease within 3 days of registration
Radiotherapy:
- No prior radiotherapy
Surgery:
- 10-28 days since prior surgical resection OR
- At least 5 days since prior biopsy
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): NCT00003309
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Illinois | |
| Veterans Affairs Medical Center - Lakeside Chicago | |
| Chicago, Illinois, United States, 60611-4494 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-6307 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| Study Chair: | Paul L. Moots, MD | Vanderbilt-Ingram Cancer Center | |
| Study Chair: | Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Study Chair: | Geoffrey R. Barger, MD | Barbara Ann Karmanos Cancer Institute |
Publications of Results:
| Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003309 History of Changes |
| Other Study ID Numbers: |
CDR0000066256 E4397 SWOG-E4397 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | January 27, 2010 |
| Last Verified: | January 2010 |
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adult medulloblastoma adult anaplastic ependymoma adult ependymoma adult supratentorial primitive neuroectodermal tumor (PNET) |
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Ependymoma Nervous System Neoplasms Central Nervous System Neoplasms Medulloblastoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Neuroectodermal Tumors, Primitive |
Cyclophosphamide Etoposide Vincristine Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors |