Irinotecan in Treating Children With Refractory or Progressive Solid Tumors

• Status: Completed
• Trial end date: 2005-01-01
• 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.

PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have refractory or progressive solid tumors.

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

Details

• Lead Sponsor: Texas Children's Cancer Center
• Treatments: Camptothecin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor refractory to standard therapy or for which no known effective therapy exists

• Brain tumors eligible

• Histologic verification waived for brain stem gliomas

• Evaluable disease

• No bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

• 1 to 21

Performance status:

• Karnofsky 50-100% (over age 10)

• Lansky 50-100% (age 10 and under)

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 8 g/dL

Hepatic:

• Bilirubin less than 1.5 mg/dL

• SGPT less than 5 times normal

Renal:

• Creatinine normal OR

• Glomerular filtration rate at least 70 mL/min

Other:

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 6 months since prior autologous bone marrow transplantation (BMT) (not including stem cell rescue after high-dose chemotherapy)

• At least 1 week since prior growth factors

• No prior BMT with total body irradiation (stratum I)

• No prior BMT with or without total body irradiation (stratum 2)

• No prior allogeneic BMT (all strata)

• No concurrent sargramostim (GM-CSF)

• No other concurrent prophylactic growth factor support during the first course of therapy

Chemotherapy:

• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

• No prior irinotecan

• No more than 2 prior multi-agent chemotherapy regimens (stratum 2)

• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks prior to study

Radiotherapy:

• At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis

• At least 6 weeks since other prior substantial bone marrow radiotherapy

• No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal radiotherapy (stratum 2)

Surgery:

• Not specified

Other:

• Recovered from all prior therapy

• No other concurrent investigational agents

• Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum 3)

• Concurrent valproic acid allowed if combined with another enzyme inducing anticonvulsant drug (stratum 3)