High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors

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Brief Title

High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors

Official Title

High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy

Brief Summary

      RATIONALE: 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: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem
      cell transplantation in treating patients with refractory solid tumors.
    

Detailed Description

      OBJECTIVES:

        -  Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem
           cell rescue and filgrastim in patients with malignancies refractory to conventional
           chemotherapy or for whom conventional therapy is not available.

        -  Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following
           high dose thiotepa.

      OUTLINE: Patients are stratified by type of tumor (neuroectodermal CNS tumor vs
      non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS tumor).

      Autologous stem cells are obtained prior to the administration of thiotepa. Patients who do
      not have peripheral blood stem cells available may undergo a bone marrow harvest instead.
      Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days. Stem cells are
      reinfused approximately 72 hours following the completion of thiotepa. Filgrastim is
      administered the day following reinfusion of stem cells and continues until there is
      sufficient hematopoietic recovery.

      The second course of thiotepa is administered 4 weeks following the first course in patients
      who have responding or stable disease, adequate stem cells, and no unacceptable toxicity.
      Patients receive a maximum of 2 courses.

      PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 2 years.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Brain and Central Nervous System Tumors

Intervention

filgrastim


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

36

Start Date

September 1997

Completion Date

May 2003

Primary Completion Date

May 2003

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Malignant solid tumors

          -  Must have failed conventional treatment or for whom conventional therapy is not
             available

          -  Measurable disease by MRI or CT scan

               -  Intraocular retinoblastomas may be measured by direct visualization

               -  Germ cell tumors may be measured by tumor markers

          -  No known bone marrow involvement

        PATIENT CHARACTERISTICS:

        Age:

          -  Any age

        Performance status:

          -  Lansky 60-100% for patients 16 and under

          -  Karnofsky 60-100% for patients over 16

        Life expectancy:

          -  At least 8 weeks

        Hematopoietic:

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 75,000/mm^3

          -  If parameters not met, must have adequate stem cell yield

        Hepatic:

          -  Bilirubin no greater than 1.5 times the upper limit of normal (ULN)

          -  SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor)

        Renal:

          -  Creatinine within normal limits OR

          -  Creatinine clearance at least 70 mL/min

        Cardiovascular:

          -  Fractional shortening greater than 28% on echocardiogram OR

          -  Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa

        Pulmonary:

          -  DLCO greater than 55% of predicted (only required if there is clinical evidence of
             pulmonary dysfunction)

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Prior bone marrow or peripheral blood stem cell rescue allowed

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than
             1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate
             stem cells collected to predict hematopoietic recovery)

          -  No concurrent chemotherapy except for dexamethasone for antiedema effects

        Endocrine therapy:

          -  No concurrent use of corticosteroids used solely as antiemetics

        Radiotherapy:

          -  At least 4 weeks since radiotherapy if absolute neutrophil count is less than
             1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate
             stem cells collected to predict hematopoietic recovery)

          -  No concurrent radiotherapy

        Surgery:

          -  Not specified
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ira Dunkel, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00003173

Organization ID

97-089

Secondary IDs

P30CA008748


Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Ira Dunkel, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

March 2013