Stage IVB Adult Soft Tissue SarcomaPhase 2NCT00019968
Isolated Limb Perfusion of Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Soft Tissue Sarcoma of the Arm or Leg
A Phase 2 study testing melphalan and tumor necrosis factor in people with Stage IVB Adult Soft Tissue Sarcoma and Stage IIB Adult Soft Tissue Sarcoma, run by National Institutes of Health Clinical Center (CC).
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells and cause less damage to healthy tissues. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Stage IVB Adult Soft Tissue Sarcoma, Stage IIB Adult Soft Tissue Sarcoma, Stage IIC Adult Soft Tissue Sarcoma
- What is being tested?
- melphalan and tumor necrosis factor
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1999to Mar 2002
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically or cytologically proven unresectable high grade soft tissue sarcoma of the extremity Measurable disease All disease must be distal to the apex of the femoral triangle in the lower limb and distal to the deltoid insertion in the upper limb Must have no local resection option according to the consensus of staff surgeons and require amputation or resection of major nerves or vascular structures to control disease Metastatic disease allowed if patient would benefit from palliative treatment of primary tumor No prior limb perfusion No newly diagnosed pediatric sarcomas that have curative potential with other chemotherapeutic regimens (i.e., newly diagnosed Ewing's sarcoma, rhabdomyosarcoma, etc.) --Prior/Concurrent Therapy-- Biologic therapy: At least 1 month since prior biologic therapy and recovered Chemotherapy: No prior melphalan At least 1 month since other prior chemotherapy and recovered No more than 1 prior systemic chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior radiotherapy and recovered Surgery: Not specified Other: No concurrent immunosuppressive drugs or chronic anticoagulants that cannot be temporarily discontinued --Patient Characteristics-- Age: 15 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm3 Coagulation studies within 1 second of normal Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No severe peripheral vascular disease (no prior claudication or other ischemic peripheral vascular manifestations) Other: Weight greater than 30 kg Not pregnant or nursing Negative pregnancy test No active infection HIV negative
About this study
Official title: Phase II Randomized Study of Isolated Limb Perfusion Using Melphalan With or Without Tumor Necrosis Factor in Patients With Unresectable High Grade Soft Tissue Sarcomas of the Extremity
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor necrosis factor is more effective than melphalan alone for soft tissue sarcoma.
PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have soft tissue sarcoma of the arm or leg.
Read the detailed description
OBJECTIVES: I. Determine the response rates, duration of response, patterns of recurrence and overall survival in patients with unresectable high grade soft tissue sarcomas of the extremity following isolated limb perfusion (ILP) using melphalan with or without tumor necrosis factor (TNF).
II. Determine the application of these regimens as neoadjuvant therapy to render an unresectable sarcoma resectable.
III. Determine whether either regimen results in durable disease control and limb salvage for patients with multifocal unresectable high grade soft tissue sarcoma of the extremity or patients with stage IV soft tissue sarcoma with symptomatic primary extremity tumor.
PROTOCOL OUTLINE: This is a randomized study.
Patients are randomized to 1 of 2 treatment arms:
Arm I: Patients receive isolated limb perfusion (ILP) with tumor necrosis factor (TNF) and melphalan. After the limb is warmed, TNF is injected into the arterial line of the extracorporeal ILP circuit over 2-3 minutes beginning at time 0, and perfusion proceeds for another 25 minutes. Melphalan is injected into the same line over 3-5 minutes and perfusion with both drugs continues for another 60 minutes.
Arm II: Patients receive ILP with melphalan alone. Melphalan is injected into the arterial line of the extracorporeal ILP circuit over 3-5 minutes beginning approximately 30 minutes after initiation of perfusion as in arm I, and perfusion proceeds for 60 minutes.
Patients with potentially curable localized disease undergo a definitive local resection 4-12 weeks following ILP at the time of maximum tumor response as determined by physical exam and CT or MRI. Patients with microscopically positive viable tumor margins following resection receive adjuvant external beam radiotherapy as clinically indicated. If definitive local control cannot be confirmed with either local excision or biopsies, then amputation is recommended in the absence of unresectable metastatic disease. Local resection may also be performed on patients who achieve partial response. Patients with unresectable metastatic pulmonary disease who are undergoing ILP for palliative purposes do not undergo definitive resection.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 4 months thereafter in the absence of disease progression. Patients expected to undergo interval resection are followed every 4 weeks until the procedure is scheduled.
PROJECTED ACCRUAL:
A total of 12-40 patients (6-20 per arm) will be accrued for this study.
- Conditions
- Stage IVB Adult Soft Tissue Sarcoma, Stage IIB Adult Soft Tissue Sarcoma, Stage IIC Adult Soft Tissue Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage IVA Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma
- Being tested
- melphalan, tumor necrosis factor
- Keywords
- adult soft tissue sarcoma, adult solid tumor, body system/site cancer, cancer, muscle cancer, musculoskeletal cancer, recurrent adult soft tissue sarcoma, solid tumor, stage IA, IB, and IIA adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage IIB adult soft tissue sarcoma, stage IIB, IIC, and III adult soft tissue sarcoma, stage IIC adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, stage IVA adult soft tissue sarcoma, stage IVB adult soft tissue sarcoma, stage, adult soft tissue sarcoma
- Medical subject headings
- Sarcoma, Neoplasms, Muscle Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melphalanDrug
tumor necrosis factorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startAug 1999
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IVB Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- H. Richard Alexander, Jr., Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019968
- Sponsor's protocol ID
- 990145
- Other IDs
- 99-C-0145, NCI-T99-0067, CDR0000067351
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2007
- Last updated
- 31 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Isolated Limb Perfusion Using Melphalan With or Without Tumor Necrosis Factor in Patients With Unresectable High Grade Soft Tissue Sarcomas of the Extremity
- ClinicalTrials.gov ID
- NCT00019968
- Acronym / sponsor ID
- 990145
- Conditions
- Stage IVB Adult Soft Tissue Sarcoma, Stage IIB Adult Soft Tissue Sarcoma, Stage IIC Adult Soft Tissue Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage IVA Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma
- Keywords
- adult soft tissue sarcoma, adult solid tumor, body system/site cancer, cancer, muscle cancer, musculoskeletal cancer, recurrent adult soft tissue sarcoma, solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Aug 1999
- Study completion
- Mar 2002 (actual)
- First posted
- 5 Mar 2007 (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. Infusing melphalan directly to the tumor may kill more tumor cells and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor necrosis factor is more effective than melphalan alone for soft tissue sarcoma.
PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have soft tissue sarcoma of the arm or leg.
Detailed description
OBJECTIVES: I. Determine the response rates, duration of response, patterns of recurrence and overall survival in patients with unresectable high grade soft tissue sarcomas of the extremity following isolated limb perfusion (ILP) using melphalan with or without tumor necrosis factor (TNF).
II. Determine the application of these regimens as neoadjuvant therapy to render an unresectable sarcoma resectable.
III. Determine whether either regimen results in durable disease control and limb salvage for patients with multifocal unresectable high grade soft tissue sarcoma of the extremity or patients with stage IV soft tissue sarcoma with symptomatic primary extremity tumor.
PROTOCOL OUTLINE: This is a randomized study.
Patients are randomized to 1 of 2 treatment arms:
Arm I: Patients receive isolated limb perfusion (ILP) with tumor necrosis factor (TNF) and melphalan. After the limb is warmed, TNF is injected into the arterial line of the extracorporeal ILP circuit over 2-3 minutes beginning at time 0, and perfusion proceeds for another 25 minutes. Melphalan is injected into the same line over 3-5 minutes and perfusion with both drugs continues for another 60 minutes.
Arm II: Patients receive ILP with melphalan alone. Melphalan is injected into the arterial line of the extracorporeal ILP circuit over 3-5 minutes beginning approximately 30 minutes after initiation of perfusion as in arm I, and perfusion proceeds for 60 minutes.
Patients with potentially curable localized disease undergo a definitive local resection 4-12 weeks following ILP at the time of maximum tumor response as determined by physical exam and CT or MRI. Patients with microscopically positive viable tumor margins following resection receive adjuvant external beam radiotherapy as clinically indicated. If definitive local control cannot be confirmed with either local excision or biopsies, then amputation is recommended in the absence of unresectable metastatic disease. Local resection may also be performed on patients who achieve partial response. Patients with unresectable metastatic pulmonary disease who are undergoing ILP for palliative purposes do not undergo definitive resection.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 4 months thereafter in the absence of disease progression. Patients expected to undergo interval resection are followed every 4 weeks until the procedure is scheduled.
PROJECTED ACCRUAL:
A total of 12-40 patients (6-20 per arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- 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 | – |
| tumor necrosis factor | Drug | – |
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 31 Oct 2023.
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. Richard Alexander, Jr. study chair
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melphalan and tumor necrosis factor in people with Stage IVB Adult Soft Tissue Sarcoma and Stage IIB Adult Soft Tissue Sarcoma, run by National Institutes of Health Clinical Center (CC).
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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 31 Oct 2023.