Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Dacarbazine; O(6)-benzylguanine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to:

• Rhabdomyosarcoma and other soft tissue sarcomas

• Ewing's family of tumors

• Osteosarcoma

• Neuroblastoma

• Wilms' tumor

• Hepatic tumors

• Germ cell tumors

• Primary brain tumor

• Histological confirmation may be waived for brainstem or optic gliomas

• Measurable or evaluable disease

• Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery

PATIENT CHARACTERISTICS:

Age:

• 21 and under

Performance status:

• ECOG 0-2

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute granulocyte count greater than 1,500/mm^3

• Hemoglobin greater than 8 g/dL

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin normal

• SGPT less than 2 times upper limit of normal

• No significant hepatic dysfunction

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No significant cardiac dysfunction

Pulmonary:

• No significant pulmonary dysfunction

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to swallow capsules

• No significant unrelated systemic illness that would preclude study (e.g., serious infections or organ dysfunction)

• No prior hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G- CSF], sargramostim [GM-CSF], or epoetin alfa)

• At least 4 months since prior myeloablative therapy requiring bone marrow or stem cell transplantation

• No concurrent anticancer immunotherapy

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered

• Prior temozolomide allowed provided not administered within past 3 months, no severe toxicities experienced during prior course, and not given in combination with other agents designed to inactivate alanine-glyoxylate aminotransferase

• No other concurrent investigational or standard anticancer chemotherapy

Endocrine therapy:

• Concurrent corticosteroids for control of brain tumor-associated edema allowed provided on stable or decreasing dose for at least 1 week prior to study

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior limited-field radiotherapy

• At least 4 months since prior craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis

• Recovered from prior radiotherapy

• No concurrent anticancer radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 4 weeks since other prior investigational therapy and recovered

• No other concurrent anticancer investigational agents