High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy |
| Estimated Enrollment: | 36 |
| Study Start Date: | September 1997 |
| Study Completion Date: | May 2003 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Ira Dunkel, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003173 History of Changes |
| Other Study ID Numbers: | 97-089, P30CA008748, MSKCC-97089A3, NYU-97-7, NCI-G97-1366 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Federal Government |
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:
|
Nervous System Neoplasms Ovarian Neoplasms Retinoblastoma Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms by Site Nervous System Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Retinal Neoplasms Eye Neoplasms Eye Diseases Retinal Diseases Thiotepa Lenograstim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013