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NCT00638898CompletedPhase 1

Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor

Pilot Study of High-Dose Chemotherapy With Busulfan, Melphalan, and Topotecan Followed by Autologous Hematopoietic Stem Cell Transplant in Advanced Stage and Recurrent Tumors

Source: ClinicalTrials.gov · Last updated 20 Mar 2025

Brief summary (registry, in English)

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This clinical trial is studying how well giving busulfan, melphalan, and topotecan hydrochloride together with a stem cell transplant works in treating patients with newly diagnosed or relapsed solid tumor.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
25 (actual)
First submitted
18 Mar 2008
Start date
Feb 2007
Primary completion date
Jan 2013
Lead sponsor
City of Hope Medical Center
NCT number
NCT00638898

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 25
  • From Feb 2007 to the primary completion date, Jan 2013
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Inclusion
  • Patients with relapsed neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, PNET, brain tumors, soft tissue sarcomas, Wilm's tumors, germ cell tumors or other solid tumors who achieved at least partial response (PR) to chemotherapy, surgery, or radiotherapy
  • Newly diagnosed patients for poor-risk pediatric solid tumors: metastatic Ewing's, metastatic PNET, rhabdomyosarcoma, soft tissue sarcomas, octeomesenchymoma, and others that are at a high risk of relapse and who have achieved at least partial response (PR) to chemotherapy, surgery, or radiotherapy
  • For any of the above categories, an attempt to achieve a complete response (CR) or PR should be made; pre-transplant modalities may include surgery, chemotherapy, or radiation therapy; radiation must not include lung fields; only patients in CR or PR at the primary site will be eligible
  • HIGH-DOSE CHEMOTHERAPY: Histologically confirmed diagnosis by Anatomic Pathology Department; if recurrent or metastatic disease, histologic confirmation should be obtained, with the exception of brain stem tumors; in neuroblastoma, demonstration of marrow metastases with elevated urinary catecholamines is adequate for diagnosis
  • HIGH-DOSE CHEMOTHERAPY: No contraindications to the stem cell collection by apheresis or by bone marrow harvesting
  • HIGH-DOSE CHEMOTHERAPY: All patients, or their legal guardians must have signed a voluntary informed consent in accordance with the institutional and federal guidelines
  • HIGH-DOSE CHEMOTHERAPY: Adequate renal function as demonstrated by creatinine clearance (12 or 24 hour urine collection) or glomerular filtration rate (GFR) \> 60 ml/min/1.73m\^2
  • HIGH-DOSE CHEMOTHERAPY: Adequate cardiac function as demonstrated by ejection fraction \> 55% by echocardiogram or MUGA
  • HIGH-DOSE CHEMOTHERAPY: Adequate hepatic function as demonstrated by bilirubin \< 2 mg/dL, SGOT and SGPT \< 5 x upper limits of normal
  • HIGH-DOSE CHEMOTHERAPY: Adequate bone marrow function as evidenced by platelet count \> 50,000/ul and absolute granulocyte count \>= 750 ul
  • HIGH-DOSE CHEMOTHERAPY: Adequate pulmonary function adults (older than 16 years): FEV1 \> 2 liters, room air PaO2 \> 70 mm Hg, room air PaCO2 \< 42 mm Hg, and DLCO \> 50% predicted; children (younger than 16 years): DLCO \> 50% predicted
  • HIGH-DOSE CHEMOTHERAPY: Pretreatment tests and clinical and laboratory tests must have been performed within 4 weeks prior to initiation of high-dose chemotherapy
  • HIGH-DOSE CHEMOTHERAPY: No other medical and/or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptable risk from this regimen
  • HIGH-DOSE CHEMOTHERAPY: Greater than 2-week period of recovery from prior modality used to control primary or recurrent site
    • Exclusion
  • Histologically confirmed bone marrow metastases within 30 days prior to transplant; prior bone marrow metastases with clearing of bone marrow (\< 5% contamination as measured by bilateral bone marrow biopsies) at the time for evaluation for this protocol is acceptable
  • Karnofsky performance status \< 60% or Lansky performance status \< 50% for patients younger than 16 years old
  • Females of reproductive age who are not using adequate birth control measures or who are pregnant
  • HIV disease
  • Patients with prior treatment with myeloablative therapy are excluded

Age in the registry: 6 months to 40 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.