Gefitinib in Treating Children With Refractory Solid Tumors

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

Summary

Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor at original diagnosis

• Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists

• No primary CNS tumors or known metastases to the CNS

• Performance status - Karnofsky 50-100% (over 10 years of age)

• Performance status - Lansky 50-100% (10 years of age and under)

• At least 8 weeks

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

• Platelet count at least 50,000/mm^3 (transfusion independent)

• Hemoglobin at least 8.0 g/dL (RBC transfusion allowed)

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT no greater than 3 times ULN

• Albumin at least 2 g/dL

• Creatinine normal for age

• Glomerular filtration rate at least 70 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• At least 6 months since prior allogeneic stem cell transplantation (SCT)

• No evidence of active graft-versus-host disease

• At least 1 week since prior biologic agents

• At least 1 week since prior hematopoietic growth factors

• Recovered from prior immunotherapy

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

• No concurrent tamoxifen

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

• At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis (6 weeks for radiotherapy to other substantial amount of bone marrow)

• Recovered from prior radiotherapy

• No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, Amiodarone, or chloroquine)

• No concurrent enzyme-activating anticonvulsants

• No concurrent proton pump inhibitors or H-2 blockers within 4 hours of gefitinib administration