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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003173 |
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 |
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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 II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
Study ID Numbers: | CDR0000065980, MSKCC-97089A3, NYU-97-7, NCI-G97-1366 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003173 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Retinal Neoplasms Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Retinoblastoma Genital Diseases, Female Neoplasms, Germ Cell and Embryonal Neuroepithelioma Ovarian Cancer Alkylating Agents Nervous System Neoplasms Retinal Diseases Endocrine Gland Neoplasms |
Extragonadal Germ Cell Tumor Ovarian Neoplasms Eye Neoplasms Testicular Cancer Eye Diseases Malignant Germ Cell Tumor Genital Neoplasms, Female Endocrine System Diseases Testicular Neoplasms Immunosuppressive Agents Recurrence Thiotepa Neuroectodermal Tumors Antineoplastic Agents, Alkylating Endocrinopathy |
Retinal Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Retinoblastoma Genital Diseases, Female Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal |
Alkylating Agents Nervous System Neoplasms Retinal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Eye Neoplasms Eye Diseases Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases Immunosuppressive Agents Pharmacologic Actions Thiotepa Adnexal Diseases |