Melanoma (Skin)Phase 2NCT00002973
Melphalan and Whole-Body Hyperthermia in Treating Patients With Advanced Melanoma
A Phase 2 study testing melphalan and hyperthermia treatment in people with Melanoma (Skin), run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- melphalan and hyperthermia treatment
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1995to Dec 2000
- 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 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed advanced melanoma beyond hope of surgical cure or metastatic disease Tumors 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: 16 and over 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 mEq/L Potassium 3.0-5.0 mg/dL Cardiovascular: No organic heart disease, including: - coronary artery disease - history of angina - history of dysrhythmia requiring ongoing medical intervention - uncontrolled hypertension - patients requiring beta blockers Neurologic: 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 compounds No development of malignant hyperthermia after general anesthesia No unexplained persistent fever Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biologic therapy Chemotherapy: At least 8 weeks since nitrosoureas (e.g., lomustine, carmustine, mitomycin) At least 4 weeks since any other chemotherapy Recovered from all toxic effects No concurrent chemotherapy Endocrine therapy: At least 4 weeks since endocrine therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since radiotherapy No prior irradiation of more than 25% of the marrow Surgery: Not specified Other: No concurrent nonsteroidal antiinflammatory agents or aspirin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia in treating patients with advanced melanoma.
Read the detailed description
OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and melphalan (L-PAM) in patients with advanced melanoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and L-PAM in these patients. IV. Obtain pilot data on the effect of WBH and L-PAM on cytokine induction in these patients.
OUTLINE: The combination of whole body hyperthermia (WBH) and melphalan (L-PAM) is administered on week 1. The infusion of L-PAM is administered at a constant rate over approximately 10 minutes, beginning 20 minutes after achieving target temperature of 41.8 degrees Celsius by esophageal or axillary temperature probe. WBH is continued for an additional 40 minutes for a total of 60 minutes. On week 5 or 6, patients receive another combination of WBH and L-PAM. Disease status is reevaluated at least every 2 courses. Patients without progressive disease continue therapy of WBH and L-PAM every 4 weeks for a maximum of 6 courses.
PROJECTED ACCRUAL: Approximately 34 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- melphalan, hyperthermia treatment
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melphalanDrug
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 posted16 Jun 2004 (estimated)
- Study startDec 1995
- Primary completionMay 2000
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- NCT00002973
- Sponsor's protocol ID
- CDR0000065487
- Other IDs
- WCCC-CO-9571, NCI-G97-1216
- Status last verified
- Sep 2015
- First submitted
- 1 Nov 1999
- Last updated
- 2 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00002973
- Acronym / sponsor ID
- CDR0000065487
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- 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
- Dec 1995
- Primary completion
- May 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 16 Jun 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia in treating patients with advanced melanoma.
Detailed description
OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and melphalan (L-PAM) in patients with advanced melanoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and L-PAM in these patients. IV. Obtain pilot data on the effect of WBH and L-PAM on cytokine induction in these patients.
OUTLINE: The combination of whole body hyperthermia (WBH) and melphalan (L-PAM) is administered on week 1. The infusion of L-PAM is administered at a constant rate over approximately 10 minutes, beginning 20 minutes after achieving target temperature of 41.8 degrees Celsius by esophageal or axillary temperature probe. WBH is continued for an additional 40 minutes for a total of 60 minutes. On week 5 or 6, patients receive another combination of WBH and L-PAM. Disease status is reevaluated at least every 2 courses. Patients without progressive disease continue therapy of WBH and L-PAM every 4 weeks for a maximum of 6 courses.
PROJECTED ACCRUAL: Approximately 34 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| melphalan | 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 2 Oct 2015.
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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 melphalan and hyperthermia treatment in people with Melanoma (Skin), 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 2 Oct 2015. 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 2 Oct 2015.