Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors

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Brief Title

Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors

Official Title

TREATMENT OF CHILDREN AND YOUNG ADULTS WITH RECURRENT/REFRACTORY SOLID TUMORS WITH HIGH DOSE ETOPOSIDE AND CARBOPLATIN PLUS ESCALATING DOSE CYCLOPHOSPHAMIDE, FOLLOWED BY HEMATOPOIETIC RESCUE USING AUTOLOGOUS CD34+ SELECTED BLOOD STEM CELLS: A PILOT STUDY

Brief Summary

      RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were
      destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different
      ways to stop tumor 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 tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide
      when given together with combination chemotherapy and a peripheral stem cell transplant in
      treating patients with malignant solid tumors.
    

Detailed Description

      OBJECTIVES:

        -  Determine whether autologous transplantation of mobilized CD34+ peripheral blood stem
           cells (PBSC) can provide complete hematologic reconstitution after myeloablative
           chemotherapy comprising etoposide (VP-16) and carboplatin (CBDCA) in patients with
           metastatic or recurrent rhabdomyosarcoma, neuroblastoma, Ewing's sarcoma/primitive
           neuroectodermal tumor, germ cell tumors, childhood brain tumors, or hepatoblastoma.

        -  Determine the frequency and yield of CD34+ PBSC and granulocyte-macrophage
           colony-forming units (GM-CFU) that are mobilized, harvested, and purified after a single
           priming course of high-dose cyclophosphamide (CTX) followed by filgrastim (G-CSF).

        -  Correlate the number of CD34+ cells and GM-CFU in the autologous PBSC graft with time to
           engraftment of white blood cells, neutrophils, and platelets in these patients.

        -  Determine the optimal day of PBSC harvest after a single priming course of high-dose CTX
           and G-CSF in these patients.

        -  Determine whether CD34+ PBSC rescue and daily post-transplantation G-CSF decrease the
           time to hematopoietic recovery after high-dose VP-16 and CBDCA compared to historical
           results achieved in similar patients rescued with bone marrow.

        -  Compare the tumor cell content of marrow, mobilized blood, and purified CD34+ PBSC graft
           preparations.

        -  Determine the optimal timing of PBSC mobilization and harvest in relation to extent of
           prior chemotherapy in these patients.

        -  Determine the feasibility of a single leukapheresis for PBSC harvest in children.

        -  Determine the toxic effects of this regimen in these patients.

        -  Determine the antitumor activity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of cyclophosphamide.

      Mobilization/harvest: Patients receive cyclophosphamide IV over 90 minutes on day 0 and
      filgrastim (G-CSF) subcutaneously or IV over 30 minutes on days 2-15 or until blood counts
      recover. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells on day
      15. Bone marrow is also harvested in case insufficient PBSC are harvested.

      Preparative regimen/transplantation: Patients receive carboplatin IV over 1 hour and
      etoposide IV continuously on days -6 to -4. Cyclophosphamide is administered IV over 1 hour
      on days -3 and -2 or IV continuously on days -3 and -2, -4 to -2, -5 to -2, or -6 to -2. PBSC
      or bone marrow is reinfused on day 0.

      Cohorts of 3-10 patients receive escalating doses of cyclophosphamide until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 20% of
      patients experience dose-limiting toxicity.

      At least 6 additional patients receive cyclophosphamide at the MTD.

      PROJECTED ACCRUAL: A minimum of 36 patients will be accrued for this study.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Brain and Central Nervous System Tumors

Intervention

filgrastim

Study Arms / Comparison Groups

 Arm 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

21

Start Date

May 31, 1997

Completion Date

February 1, 2005

Primary Completion Date

February 1, 2005

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically proven malignant solid tumor, including any of the following:

               -  Rhabdomyosarcoma

               -  Neuroblastoma

               -  Ewing's sarcoma/primitive neuroectodermal tumor

               -  Germ cell tumors

               -  Childhood brain tumors

               -  Hepatoblastoma

          -  Metastatic disease OR has failed at least first-line therapy

          -  Ineligible for higher priority protocols

        PATIENT CHARACTERISTICS:

        Age:

          -  Under 36 at transplantation

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 8 weeks

        Hematopoietic:

          -  Absolute neutrophil count at least 1,000/mm3

          -  Platelet count at least 75,000/mm3

        Hepatic:

          -  Bilirubin no greater than 1.5 mg/dL

          -  Liver function tests no greater than 2 times normal OR

          -  No active hepatitis on liver biopsy

          -  No hepatitis B infection

        Renal:

          -  Creatinine no greater than 1.5 mg/dL OR

          -  Glomerular filtration rate (preferably measured) greater than 60% of normal

        Cardiovascular:

          -  Left ventricular ejection fraction at least 45%

          -  No active congestive heart failure

          -  No active arrhythmia

        Pulmonary:

          -  Age 8 and under: clinically normal pulmonary function

          -  Over age 8: FEV1 and FVC at least 50% predicted

          -  Arterial blood gases normal and DLCO at least 50% if spirograms difficult to

          -  interpret due to poor patient effort, recent surgery, or pulmonary tumor

          -  involvement

        Other:

          -  No mucositis or mucosal infection prior to myeloablative chemotherapy

          -  HIV negative

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
      

Gender

All

Ages

N/A - 35 Years

Accepts Healthy Volunteers

No

Contacts

Allen R. Chen, MD, PhD, MHS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00007813

Organization ID

JHOC-9512

Secondary IDs

CDR0000064263

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 Amgen

Study Sponsor

Allen R. Chen, MD, PhD, MHS, Study Chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Verification Date

February 2020