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Soft Tissue SarcomaPhase 2NCT00365872

External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma

A Phase 2 study testing Dendritic Cell (DC) Injections, Radiation therapy and Complete Resection - Surgery for tumor removal in people with Soft Tissue Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Dendritic Cell (DC) Injections, Radiation therapy and Complete Resection - Surgery for tumor removal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
May 2006to Jun 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Intermediate or high grade sarcoma as determined by pathology review
  • Musculoskeletal tumor in extremities, trunk or chest wall.
  • Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter.
  • Clinical Stage T2N0M0 (AJCC 6th edition)
  • Patient is not a candidate for neoadjuvant chemotherapy.
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.
Show all 17Show fewer
  • No steroid therapy within 4 weeks of first dendritic cell administration.
  • No coagulation disorder.
  • Patient's written informed consent.
  • No contraindication to resection.
  • Adequate organ function (measured within a week of beginning treatment).
  • White blood count (WBC) > 3,000/mm to the third power and absolute neutrophil count (ANC) >1500/mm to the third power
  • Platelets > 100,000/mm to the third power
  • Hematocrit > 25%
  • Bilirubin < 2.0 mg/dL
  • Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min
  • Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from radiation.

Who cannot join

  • Retroperitoneal location.
  • Gastrointestinal stromal tumor (GIST).
  • Demonstrated metastatic disease.
  • Prior radiation therapy if the current tumor is locally recurrent after prior resection.
  • Concurrent treatment with any anticancer agent other than radiation as dictated by the protocol.
  • Bleeding disorder.
Show all 11Show fewer
  • H.I.V. infection or other primary immunodeficiency disorder.
  • Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate).
  • Any serious ongoing infection.
  • Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (a pregnancy test will be obtained before treatment).
  • ECOG performance status of 2, 3 or 4.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients

This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's own immune related white blood cells into their tumor would strengthen the immune system to fight against their cancer.

Read the detailed description

Patients were treated with external beam radiation therapy (EBRT) combined with experimental intratumoral injection of dendritic cell (DC). Patients received 5,040 centigray (cGy) EBRT in 28 equal fractions. Radiation was delivered 5 days per week (Monday-Friday). DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given several days before surgery to assess DC migration. Tumors were surgically resected 3-6 weeks after the completion of EBRT.

Being tested
Dendritic Cell (DC) Injections, Radiation therapy, Complete Resection - Surgery for tumor removal
Keywords
Sarcoma, Intratumoral injection, Dendritic cells, Neo-adjuvant treatment, Immunotherapy, Pheresis, Radiation
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dendritic Cell (DC) InjectionsBiological

    • DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation.
    • One additional DC injection was given before surgery to assess DC migration
    • Patients were assigned to one of three cohorts:

    Group 1 - DC injection # 4 given 24 hours prior to surgery Group 2 - DC injection # 4 given 48 hours prior to surgery Group 3 - DC injection # 4 given 72 hours prior to surgery

  • Radiation therapyProcedure or surgery

    Radiation was delivered 5 days per week (Monday-Friday).

  • Complete Resection - Surgery for tumor removalProcedure or surgery

    Tumors were surgically resected 3-6 weeks after the completion of EBRT.

Study groups in NCT00365872
Study groupRoleWhat they receive
EBRT + DC Injection + ResectionExperimentalSingle Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts as outlined in that intervention.
Receives: Biological: Dendritic Cell (DC) Injections; Procedure: Radiation therapy; Procedure: Complete Resection - Surgery for tumor removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.

    Measured: Up to 3 years

Secondary outcomes (3)

  1. Occurrence of Significant (>/= Grade 2) Toxicity

    Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria.

    Measured: Up to 3 years

  2. Occurrence of Postoperative Wound Complications

    Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).

    Measured: Up to 3 years

  3. Participants With No Evidence of Disease at Follow-up

    Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00365872
Sponsor's protocol ID
MCC-14497
Status last verified
Jun 2013
First submitted
17 Aug 2006
Last updated
23 Mar 2017
Data monitoring committee
Yes

Publications

  • Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.

    PubMed 35135810

  • Raj S, Bui MM, Springett G, Conley A, Lavilla-Alonso S, Zhao X, Chen D, Haysek R, Gonzalez R, Letson GD, Finkelstein SE, Chiappori AA, Gabrilovitch DI, Antonia SJ. Long-Term Clinical Responses of Neoadjuvant Dendritic Cell Infusions and Radiation in Soft Tissue Sarcoma. Sarcoma. 2015;2015:614736. doi: 10.1155/2015/614736. Epub 2015 Dec 31.

    PubMed 26880867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dendritic Cell (DC) Injections, Radiation therapy and Complete Resection - Surgery for tumor removal in people with Soft Tissue Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute 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?

The sponsor lists 17 inclusion and 11 exclusion criteria. 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 23 Mar 2017. 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?

Yes. Results are posted in the registry (first posted 6 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00365872, which also lists 2 linked publications.

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 23 Mar 2017.

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