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Chemotherapy With Whole Body Hyperthermia to Treat Resistant Breast, Endometrial, Cervical and Ovarian Cancers

NCT00178802 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-04-23

No results posted yet for this study

Summary

Thermal therapy (hyperthermia of heat) can increase the effect of chemotherapy treatments. By itself, thermal therapy can also kill cancer cells. By using thermal therapy to treat the whole body, the investigators can treat cancer cells wherever they are throughout the entire body. In this study, the investigators are testing the combination of thermal therapy combined with chemotherapy to see:

1. if it improves the effect of the chemotherapy drugs,
2. if it helps the body fight the cancer cells, and
3. if this treatment is safe for the patient.

This study does not offer heat treatment alone. Any patient with advanced or metastatic breast, or endometrial cancer resistant to standard treatment may be treated with the phase II protocol therapy; however, the patient will need to undergo some medical tests to make sure this treatment would be safe for them.

Conditions

  • Breast Neoplasms
  • Endometrial Neoplasms
  • Cervix Neoplasms
  • Ovarian Neoplasms

Interventions

OTHER

thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)

5-fluorouracil 400 mg/m2 i.v. over 24 hours for 5 days Doxil (liposomal doxorubicin) 40 mg/m2 over 1 hour Fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration daily Low-dose interferon-alpha 100,000 i.u. s.c. daily for the duration of the protocol

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Joan M Bull, M.D. · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1996-06-30
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178802 on ClinicalTrials.gov