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High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003173
  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 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 36
Study Start Date: September 1997
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003173

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
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Ira Dunkel, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009