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

Primary Purpose

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
thiotepa
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 6, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003173
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Dunkel, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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