SarcomaPhase 2NCT00002974
Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma
A Phase 2 study testing carboplatin, etoposide and ifosfamide in people with Sarcoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- carboplatin, etoposide and ifosfamide
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1996to Apr 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed advanced sarcoma that is metastatic or incurable surgically Evaluable or measurable disease Must be refractory to all known forms of effective therapy No CNS tumor involvement No major liver involvement (more than 33% replacement of liver by tumor)
PATIENT CHARACTERISTICS: Age: 18-65 Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,000/mm3 Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Alkaline phosphatase no greater than 3 times normal SGOT no greater than 3 times normal Protein no less than 15% below lower limit of normal Renal: BUN less than 30 mg/dL Creatinine less than 1.5 mg/dL OR Creatinine clearance no less than 60 mL/min Calcium no greater than 11.0 mg/dL Sodium 130-150 mmol/L Potassium 3.0-5.0 mmol/L Cardiovascular: No organic heart disease - coronary artery disease - history of angina - history of dysrhythmia requiring ongoing medical intervention - uncontrolled hypertension - patients that require beta blockers - congestive heart failure Neurologic: No tumor involvement of CNS No moderate or severe peripheral neuropathy No history of severe emotional instability by psychiatric history Pulmonary: FEV1 at least 60% of predicted Maximum voluntary volume at least 60% of predicted Partial pressure of oxygen at least 60 OR Oxygen saturation at least 90% Other: No history of secondary primary cancer which conceivably could be active No active nonmalignant gastric and/or duodenal ulcer No serious infection requiring hospitalization within the previous 14 days No history of hepatitis related to general anesthesia No history of allergy to lidocaine or related compound No development of malignant hyperthermia after general anesthesia No unexplained persistent fever Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 8 weeks since nitrosoureas (e.g., CCNU, BCNU, mitomycin) At least 4 weeks since any other chemotherapy Recovered from all toxic effects Endocrine therapy: Not specified Radiotherapy: No prior irradiation of more than 25% of the marrow Surgery: Not specified Other: No concurrent nonsteroidal anti-inflammatory agents or aspirin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
About this study
Official title: A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or that cannot be surgically removed.
Read the detailed description
OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) chemotherapy in patients with advanced sarcoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and ICE in these patients. IV. Obtain pilot data on the effect of WBH and ICE on cytokine induction in these patients.
OUTLINE: Treatment of whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) is given every 3-4 weeks. On day 1 of the treatment, ifosfamide is administered intravenously over 60 minutes at the beginning of hyperthermia. Carboplatin is administered intravenously over 20 minutes while at the maximum temperature. Etoposide is administered intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after hyperthermia. Patient disease status is reevaluated after 2 courses. If there is no disease progression, treatment continues for a maximum of 4 courses.
PROJECTED ACCRUAL: Approximately 17-34 patients will be accrued for this study.
- Conditions
- Sarcoma
- Being tested
- carboplatin, etoposide, ifosfamide, hyperthermia treatment
- Keywords
- recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
etoposideDrug
ifosfamideDrug
hyperthermia treatmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2004 (estimated)
- Study startJul 1996
- Primary completionJul 2001
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- H. I. Robins, MD, PhD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002974
- Sponsor's protocol ID
- CDR0000065489
- Other IDs
- WCCC-CO-9672, NCI-G97-1217
- Status last verified
- May 2011
- First submitted
- 1 Nov 1999
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients
- ClinicalTrials.gov ID
- NCT00002974
- Acronym / sponsor ID
- CDR0000065489
- Conditions
- Sarcoma
- Keywords
- recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1996
- Primary completion
- Jul 2001 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 30 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or that cannot be surgically removed.
Detailed description
OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) chemotherapy in patients with advanced sarcoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and ICE in these patients. IV. Obtain pilot data on the effect of WBH and ICE on cytokine induction in these patients.
OUTLINE: Treatment of whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) is given every 3-4 weeks. On day 1 of the treatment, ifosfamide is administered intravenously over 60 minutes at the beginning of hyperthermia. Carboplatin is administered intravenously over 20 minutes while at the maximum temperature. Etoposide is administered intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after hyperthermia. Patient disease status is reevaluated after 2 courses. If there is no disease progression, treatment continues for a maximum of 4 courses.
PROJECTED ACCRUAL: Approximately 17-34 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| hyperthermia treatment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. I. Robins, MD, PhD study chair
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, etoposide and ifosfamide in people with Sarcoma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.