INCLUSION CRITERIA:
1. Age: Patients must be less than or equal to 21 years of age.
2. Histological diagnosis: Patients must have a histologically confirmed solid tumor, which may include, but is not limited to, rhabdomyosarcoma and other soft tissue sarcomas, Ewing's family tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors or primary brain tumor. For patients with brainstem gliomas or optic gliomas, the requirement for histological confirmation may be waived.
3. Prior therapy:
3.1 The patient's tumor must be refractory to standard treatment. Patients must have no known potentially curative therapy available to them. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities.
3.2 Patients must have had their last dose of limited-field radiation therapy at least four weeks prior to study entry. Patients who have received extensive prior radiation therapy (craniospinal radiation, total body radiation, or radiation to more than half of the pelvis) must be at least 4 months post-completion of radiation therapy. Patients must have received their last dose of chemotherapy at least three weeks prior to study entry (four weeks for nitrosoureas), and their last investigational therapy at least four weeks prior to study entry.
3.3 Patients must have recovered from the toxic effects of all prior therapy prior to entry onto this trial.
3.4 Patients with brain tumors who are receiving corticosteroids for the control of tumor-associated edema must be on a stable or decreasing dose for at least 1 week prior to study enrollment.
3.5 Patients who have previously received temozolomide are eligible if they have not received the drug in the past 3 months and they did not experience severe toxicities during their previous course of therapy with temozolomide. Severe toxicity is defined as any grade 4 non-hematologic toxicity or failure to recover (to grade less than or equal to 1 level) from any non-hematologic or hematologic toxicity within six weeks of receiving temozolomide. Patients who received temozolomide in combination with other agents that were designed to inactivate AGT are not eligible for this trial.
3.6 Patients should be off colony stimulating factors such as G-CSF, GM-CSF, and Epo for at least one week prior to study entry.
4. Measurable/Evaluable disease: Patients must have measurable or evaluable disease. There must be evidence of progressive disease on prior chemotherapy or radiation therapy or persistent disease after surgery.
5. Performance status: Patients should have an ECOG performance status of 0, 1, or 2 and a life expectancy of at least eight (8) weeks. Patients who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score.
6. Hematological function: Patients must have adequate bone marrow function defined as a peripheral absolute granulocyte count of greater than 1500/mm(3), hemoglobin greater than 8 gm/dL, and platelet count greater than 100,000/mm(3).
7. Hepatic function: Patients must have adequate liver function, defined as bilirubin within normal limits and SGPT less than 2 times the upper limit of normal.
8. Renal function: Patients must have an age-adjusted normal serum creatinine or a creatinine clearance greater than or equal to 60 mL/min/1.73 m(2).
9. Patients must be able to swallow capsules.
10. Informed consent: All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and their risks of this study before any protocol related studies are performed. When appropriate, pediatric patients will be included in all discussions in order to obtain verbal assent.
11. Durable Power of Attorney (DPA): Assignment of a DPA to a family member or guardian should be offered to all patients 18 to 21 years of age who have a brain tumor.
EXCLUSION CRITERIA:
1. Patients currently receiving other investigational chemotherapeutic agents.
2. Patients with a history of myeloablative therapy requiring bone marrow or stem cell transplantation within the previous 4 months.
3. Pregnant or breast-feeding females are excluded.
4. Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results.
5. Patients with a history of hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol (PEG).
Warren Grant Magnuson Clinical Center (CC)