Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Biological: sargramostim Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 1995 |
OBJECTIVES:
- Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and cyclophosphamide in children with relapsed acute lymphocytic leukemia.
- Determine the dose effect of autologous PBSC on engraftment in this patient population.
OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units, and CD34+ cells.
Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation.
Patients are followed at 100 days, 6 months, and 1 year.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 1 Year to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia
- Pathologic evidence of relapse in marrow, CNS, or testes
- In second or later complete remission
Ineligible for allogeneic transplantation:
- No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR
- Ineligible for preparative regimen including total-body irradiation
Peripheral blood stem cell collection feasible:
- Patient size generally at least 8 kg
- Able to place central venous catheter
- Patient cooperative
PATIENT CHARACTERISTICS:
Age:
- 1 to 19
Performance status:
- Not moribund
Life expectancy:
- No severe limits from disease other than leukemia
Hepatic:
- Bilirubin no greater than 3 times normal for age
- AST and/or GGT no greater than 3 times normal for age
- No evidence of hepatic synthetic dysfunction
Renal:
- GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance
Cardiovascular:
- Cardiac contractility normal on echocardiogram
Pulmonary:
- FVC and FEV_1 with or without DLCO at least 50% predicted
Other:
- No significant active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Contacts and Locations| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| Study Chair: | Bruce G. Gordon, MD | University of Nebraska |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002638 History of Changes |
| Other Study ID Numbers: | CDR0000064114, UNMC-06695, NCI-V95-0639 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Cyclophosphamide Cytarabine Etoposide Lenograstim Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013