Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors

• Status: Completed
• Trial end date: 2003-12-01
• 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 combining carboplatin and irinotecan in treating children who have refractory solid tumors.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Carboplatin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor, including primary brain tumor

• Progressive disease on standard therapy or for which no standard therapy exists

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• 1 to 21

Performance status:

• Lansky 50-100% (age 10 and under)

• Karnofsky 50-100% (over age 10)

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm3

• Platelet count greater than 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• ALT no greater than 2.5 times upper limit of normal

Renal:

• Glomerular filtration rate at least 30 mL/min

Other:

• No active infection

• No serious uncontrolled medical disorder

• No psychiatric disorder or other disorder that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease

• At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunotherapy

Chemotherapy:

• No more than 3 prior chemotherapy regimens

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent hormone replacement therapy or oral contraceptives allowed

• No other concurrent hormonal therapy

Radiotherapy:

• At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent investigational anticancer drugs

• No other concurrent antitumor therapy

• No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)