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