Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors

• 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. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Sargramostim

Criteria

DISEASE CHARACTERISTICS: Histologically proven (except for brain stem tumors) malignancy that has

failed or relapsed after standard first-line antineoplastic therapy

• Sarcoma (soft tissue and bone)

• Kidney tumors

• Brain tumors

• Other solid tumors (gonadal and germ cell tumors, malignant melanoma,

• retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks

No bone marrow involvement

No prior or concurrent myelogenous leukemia

PATIENT CHARACTERISTICS:

Age:

• 1 to 21

Performance status:

• Lansky or Karnofsky 60-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1000/mm3

• Platelet count greater than 100,000/mm3

• No grade III or IV thrombosis

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT less than 2.5 times ULN

Renal:

• Creatinine clearance or glomerular filtration rate at least 70 mL/min

Cardiovascular:

• Ejection fraction normal

• No evidence of arrhythmias requiring therapy

• Fractional shortening greater than 28%

Other:

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 10 days since prior colony-stimulating factor therapy and recovered

• At least 30 days since prior epoetin alfa

• No other concurrent cytokines, including epoetin alfa

Chemotherapy:

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

• recovered

• At least 3 months since therapy with etoposide, carboplatin, or ifosfamide

• that is identical to study treatment

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent radiotherapy allowed after third course of therapy

• No prior cranial/spinal radiotherapy

• No prior radiotherapy to greater than 50% of bone marrow

Surgery:

• Concurrent surgery allowed after the second course of therapy

Other:

• No concurrent investigational agents

• No concurrent lithium, aspirin, coumadin, or heparin