Search / Trial NCT00001498

A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Apply for Trial

Trial Information

Current as of March 02, 2024

Completed

Keywords

5 Fluorouracil Cyclophosphamide Methotrexate Thiotepa

Description

This pilot trial will examine the feasibility of administering induction high-dose therapy with antimetabolites, followed with consolidation using high-dose single alkylating agent therapy and finally intensification therapy with sequential cycles of very high doses of the natural products (paclitaxel followed by doxorubicin) to patients with metastatic breast cancer (stage IV), and to patients with lesser stage disease at high risk for relapse (patients with four or more positive nodes (stage II), locally advanced breast cancer (stage III)), and patients with locally or regionally recurren...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Histologically proven AR and ESFT which includes: Classical, atypical and extraosseous Ewing's sarcoma, primitive peripheral neuroectodermal tumors, peripheral neuroepithelioma, primitive sarcoma of bone, and ectomesenchymoma.
  • Confirmed presence of tumor-specific infusion protein by documented RT-PCR which corresponds to one of the tumor specific peptides available for vaccination.
  • Measurable tumor.
  • No prior or current CNS metastases.
  • PRIOR/CONCURRENT THERAPY:
  • ARM A PATIENTS:
  • May be enrolled on the protocol for the first phase in the absence of RT PCR documentation of a tumor-specific fusion protein which corresponds to one of the tumor-specific peptides available for vaccination. However, RT PCR documentation at the time of tumor recurrence must occur prior to administration of immunotherapy. At time of initial tumor diagnosis, prior to any cytoreductive therapy.
  • ARM B PATIENTS:
  • Tumor recurrence occurring during or after receiving at least first line cytoreductive therapy for ESFT and AR. No more than two post-recurrence salvage regimens unless peripheral CD4+T cell number is greater than 400 cells per millimeter cubed.
  • At least 6 weeks since any treatments and recovered from all acute toxic effects from time in which immunotherapy will be started for this study.
  • No concurrent estrogen therapy during immunotherapy section of study.
  • PATIENT CHARACTERISTICS:
  • Age: 2-25 (at time of initial diagnosis of alveolar rhabdomyosarcoma).
  • Weight: Greater than 15 kg (at time of apheresis).
  • Performance status: ECOG 0-2.
  • Life expectancy: At least 8 weeks.
  • Hematopoietic:
  • ANC greater than 100,000/mm(3).
  • Hemoglobin greater than 9.0 g/dL.
  • Platelet count greater than 50,000/mm(3).
  • Hepatic:
  • Bilirubin less than 2.0 mg/dL (unless related to involvement by tumor).
  • Transaminases less than 3 times normal (unless related to involvement by tumor).
  • Renal:
  • Creatinine less than 1.5 mg/dL or creatinine clearance greater than 60 mL/min.
  • Cardiovascular:
  • No major disorder of cardiovascular system.
  • Cardiac ejection fraction greater than 40%.
  • Pulmonary:
  • No major disorder of pulmonary system.
  • OTHER:
  • Not pregnant or nursing.
  • HIV negative.
  • Hepatitis B or C negative.
  • No patients requiring daily oral corticosteroid therapy.
  • If allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Barre syndrome, ineligible to receive influenza vaccine.

Attachments

readout_NCT00001498_2024-03-02.pdf

4.5 MB

NCT00001498_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0