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| Sponsor: | Children's Cancer Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003597 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Biological: filgrastim Biological: recombinant human thrombopoietin Drug: carboplatin Drug: etoposide Drug: ifosfamide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | A Phase I Study of Thrombopoietin (rhTPO) Plus G-CSF in Children Receiving Ifosfamide, Carboplatin, and Etoposide (I.C.E.) Chemotherapy for Recurrent or Refractory Solid Tumors |
| Estimated Enrollment: | 24 |
| Study Start Date: | November 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of recombinant human thrombopoietin.
All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4. Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days.
Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4, 6, 8, 10, and 12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity. After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000/mm3 for 2 consecutive days or day 33.
PROJECTED ACCRUAL: A total of 24 evaluable patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven (except for brain stem tumors) malignancy that has
failed or relapsed after standard first-line antineoplastic therapy
No bone marrow involvement
No prior or concurrent myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 24 Study Locations| Study Chair: | Mitchell S. Cairo, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000066668, CCG-09717 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003597 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood rhabdomyosarcoma recurrent renal cell cancer recurrent neuroblastoma recurrent childhood liver cancer recurrent Wilms tumor and other childhood kidney tumors recurrent retinoblastoma childhood central nervous system germ cell tumor recurrent osteosarcoma recurrent gestational trophoblastic tumor recurrent malignant testicular germ cell tumor recurrent intraocular melanoma recurrent melanoma unspecified childhood solid tumor, protocol specific childhood germ cell tumor |
recurrent childhood soft tissue sarcoma recurrent ovarian germ cell tumor extragonadal germ cell tumor recurrent uterine sarcoma neutropenia thrombocytopenia recurrent childhood brain stem glioma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
|
Ifosfamide Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Carboplatin |
Alkylating Agents Antineoplastic Agents, Phytogenic Etoposide phosphate Etoposide Pharmacologic Actions Isophosphamide mustard |