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

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ClinicalTrials.gov Identifier: NCT00003173
Recruitment Status : Completed
First Posted : April 23, 2003
Last Update Posted : March 7, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer Retinoblastoma Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Biological: filgrastim Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy
Study Start Date : September 1997
Primary Completion Date : May 2003
Study Completion Date : May 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 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


  • 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


  • 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)


  • Creatinine within normal limits OR
  • Creatinine clearance at least 70 mL/min


  • Fractional shortening greater than 28% on echocardiogram OR
  • Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa


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


  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior bone marrow or peripheral blood stem cell rescue allowed


  • 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


  • 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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003173

United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Ira Dunkel, MD Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier: NCT00003173     History of Changes
Other Study ID Numbers: 97-089
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2003    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
intraocular retinoblastoma
recurrent retinoblastoma
childhood central nervous system germ cell tumor
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
unspecified childhood solid tumor, protocol specific
unspecified adult solid tumor, protocol specific
childhood germ cell tumor
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
extragonadal germ cell tumor
adult central nervous system germ cell tumor
childhood teratoma
childhood malignant testicular germ cell tumor
childhood malignant ovarian germ cell tumor
childhood extragonadal germ cell tumor
recurrent childhood malignant germ cell tumor

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Eye Diseases
Retinal Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists