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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 23, 2003
Last Update Posted Date March 7, 2013
Study Start Date  ICMJE September 1997
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: thiotepa
  • Procedure: autologous bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†20,¬†2007)
36
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2003
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003173
Other Study ID Numbers  ICMJE 97-089
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-97089A3
NYU-97-7
NCI-G97-1366
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Ira Dunkel, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP