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

NCT00178802 | Unknown Phase 2 DMC

• 1 other identifier: HSC-MS-01-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Neoplasms; Endometrial Neoplasms; Cervix Neoplasms; Ovarian Neoplasms

Keywords

breast cancer; endometrial cancer; cervical cancer; ovarian cancer

Outcome Measures

Primary Outcomes (2)

• Tumor response

  5 years

• Response duration

  5 years

Secondary Outcomes (1)

• Toxicity

  5 years

Study Arms (1)

1

OTHER

thermochemotherapy using fever-range whole-body thermal therapy combined with continuous infusion 5-fluorouracil, Doxil, and low-dose interferon-alpha.

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

Interventions

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

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

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resistant breast, endometrial, cervix, or ovarian cancer
• No active metastasis to the brain
• No more than 8 previous regimes of Doxil
• Successful completion of preliminary function tests
• Good ECOG score

You may not qualify if:

• Active metastasis to the brain
• or more previous cycles of Doxil
• Poor completion of preliminary function tests
• Poor ECOG score

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Joan M Bull, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 1996
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 23, 2010

Record last verified: 2010-04

Locations

US (1)