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PDQ® Clinical Trial Abstract |
Important: This information is intended for use by doctors and other health care professionals. If you are a cancer patient, your doctor can explain how it applies to you, or you can call the Cancer Information Service at 1-800-422-6237.
Protocol IDs: POG-9464
Protocol Type: treatment
Sponsorship: NCI-sponsored, NCI cooperative group program
Status: Active
Age Range: 21 and under at diagnosis
A total of 30 patients per stratum (brain tumor vs. other) will be entered, provided 2 or 3 of the first 12 and 4 or 5 of the first 22 patients in each stratum respond. The study will be closed to all patients if no responses are seen in the first 35 patients.
I. Determine the response rate to cyclophosphamide plus topotecan in children with refractory or recurrent solid tumors, including brain tumors. II. Describe the toxic effects of this regimen.
--Disease Characteristics--
Histologically or cytologically proven solid tumor that is refractory or
recurrent and for which no effective therapy exists, including:
Rhabdomyosarcoma Neuroblastoma
Osteosarcoma Wilms' tumor
Ewing's sarcoma/primitive neuroepithelial tumor
Other solid tumor (excluding lymphoma)
[As of 4/98, closed to patients with rhabdomyosarcoma or osteosarcoma.]
- Biopsy of recurrence recommended
- Measurable disease required
Histologically proven primary CNS tumor, including:
Ependymoma
Medulloblastoma
Brain stem glioma
Malignant glioma
Astrocytoma other than glioblastoma multiforme must be ineligible for
protocol POG-9436 and approved by Principal Investigator
Other CNS tumors
- Progressive or recurrent disease on CT or MRI after initial therapy
Biopsy to rule out radionecrosis required in patients with prior
hyperfractionated radiotherapy (encouraged in patients without prior
radiotherapy)
- Measurable disease on CT or MRI
Lesion at least 1 square centimeter on at least 1 neuroradiographic
image
Lesions previously treated by stereotactic radiotherapy or brachytherapy
are not considered measurable
Ineligible for higher priority POG protocol
--Prior/Concurrent Therapy--
Recovered from prior therapy
Biologic therapy:
Not specified
Chemotherapy:
No more than 2 prior chemotherapy regimens other than a phase I or
single-agent phase II clinical trial
No prior topotecan
Prior cyclophosphamide allowed
Bone marrow transplant considered 1 regimen
At least 3 weeks since chemotherapy (6 weeks since nitrosoureas)
Endocrine therapy:
Not specified
Radiotherapy:
At least 6 weeks since extensive radiotherapy
Surgery:
Not specified
Other:
At least 6 months since bone marrow transplant
Complete engraftment of all hematopoietic lineages required
No graft-versus-host disease
--Patient Characteristics--
Age:
21 and under at diagnosis
Performance status:
Modified Lansky 50%-100%
Life expectancy:
At least 6 weeks
Hematopoietic:
(unless secondary to bone marrow metastases)
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
ALT or AST less than 2 times normal
Renal:
Creatinine less than 1.5 mg/dL OR
Creatinine clearance at least 60% of normal for age
Other:
Weight at least 3rd percentile for age
No pregnant or nursing women
Adequate contraception required of fertile patients
All patients receive cyclophosphamide followed by topotecan for 5 days. G-CSF is given from day 6 until hematologic recovery. Treatment repeats every 21 days for a minimum of 2 courses unless disease progression or unacceptable toxicity intervenes. Patients are followed every 6 months for 4 years, then annually.
The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening for or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Robert L. Saylors, Chair,
Ph: 501-320-1494
Pediatric Oncology Group