Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy

• Status: Completed
• Trial end date: 2005-09-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed initial diagnosis of malignant solid tumor refractory to conventional therapy or for which no effective therapy exists

• Brain tumors allowed if not on anticonvulsants

• Brainstem gliomas allowed without histologic diagnosis

• Solid lymphomas allowed

• No bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

• 1 to 21

Performance status:

• Karnofsky 50-100% if over 10 years of age

• Lansky 50-100% if 10 years of age and under

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3

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

• Hemoglobin at least 8 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• ALT less than 5 times normal

• Albumin at least 2 g/dL

Renal:

• Creatinine normal for age OR

• Glomerular filtration rate normal for age

Other:

• No uncontrolled infection

• No other significant systemic illness

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior biologic therapy and recovered

• At least 1 week since prior growth factors

• No prior stem cell transplantation

Chemotherapy:

• At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered

• No more than 2 prior chemotherapy regimens

• No other concurrent cancer chemotherapy

Endocrine therapy:

• Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable or decreasing for at least 2 weeks prior to study

Radiotherapy:

• Recovered from prior radiotherapy

• At least 2 weeks since prior local palliative radiotherapy (small port)

• No prior substantial bone marrow radiotherapy

• No prior central axis radiotherapy

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No concurrent anticonvulsants

• No other concurrent anticancer therapy or investigational agents